From the Society for Vascular Surgery

One-year results from the DETOUR I trial of the PQ Bypass

DETOUR System for percutaneous femoropopliteal bypass
Dainis K. Krievins, MD, PhD,a Grzegorz Halena, MD,b Dierk Scheinert, MD,c Janis Savlovskis, MD, PhD,d
 ski, MD, PhD,e Albrecht Krämer, MD,f Kenneth Ouriel, MD,g Kasthuri Nair, BS,g
Piotr Szopin
Andrew Holden, MBChB,h and Andrej Schmidt, MD,c Riga, Latvia; Gdansk and Warsaw, Poland; Leipzig, Germany;
Santiago, Chile; New York, NY; and Auckland, New Zealand

ABSTRACT
Objective: The objective of this study was to evaluate the 1-year safety and effectiveness outcomes associated with the
PQ Bypass DETOUR System (PQ Bypass, Milpitas, Calif) for the percutaneous bypass of long-segment femoropopliteal
occlusive disease.
Methods: This prospective, single-arm, multicenter trial enrolled patients with long-segment femoropopliteal arterial
disease. The DETOUR System percutaneously deploys modular stent grafts to bypass femoropopliteal lesions through
a transvenous route. Eligible patients included those with TransAtlantic Inter-Society Consensus C and D lesions
>100 mm in length. The primary safety end point was the major adverse event (MAE) rate through 1 month, defined as
the composite of death, clinically driven target vessel revascularization (CD-TVR), or major amputation. The primary
effectiveness end point was stent graft patency through 6 months, defined as freedom from stenosis $50%, occlusion,
or CD-TVR.
Results: During a 24-month period, 78 patients (82 limbs) were enrolled. The average core laboratory-measured lesion length
was 371 6 55 mm; 79 of 82 lesions (96%) were chronic total occlusions, and 55 of 82 lesions (67%) had severe calcification. The
rates of technical and procedural success measured during the index procedure were both 96%, with satisfactory delivery and
deployment of the device without MAEs in 79 of 82 limbs. Through 1 month, there were no deaths or amputations; CD-TVRs
occurred in 2 of 81 limbs (3%), and freedom from MAEs was 98% (79/81). The 1-year Kaplan-Meier primary, assisted primary, and
secondary patency rates were 81% 6 4%, 82% 6 4%, and 90% 6 3%, respectively. The ankle-brachial index increased an average
of 0.25 6 0.27 between baseline and 1 year (P < .001). Through 1 year, the Kaplan-Meier estimates of freedom from stent graft
thrombosis, CD-TVR, and MAE were 84% 6 4%, 85% 6 4%, and 84% 6 4%, respectively. At 1 year, the Rutherford class improved
in 77 of 80 limbs (96%), and 65 of 80 (81%) were asymptomatic. Deep venous thrombosis developed in 2 of 79 target limbs (3%)
through 1 year, both at the femoropopliteal vein level. There were no instances of pulmonary embolism.
Conclusions: The 1-year results from the DETOUR I trial show that the PQ Bypass DETOUR System is a safe and effective
percutaneous treatment option for patients with longer, severely calcified, above-knee femoropopliteal lesions. (J Vasc
Surg 2020;-:1-11.)
Keywords: Femoropopliteal artery disease; Bypass; Endovascular; Claudication

Symptomatic lower extremity peripheral artery disease are not limited to open surgical autogenous or prosthetic
(PAD) most commonly occurs in the femoropopliteal bypass and endovascular interventions, such as atherec-
arterial segment.1,2 PAD treatment options include but tomy, balloon angioplasty, and stenting. Whereas

From the Department of Vascular Surgery,a and Department of Radiology,d P. investigator for Cook, BD Bard, Cagent, Endologix, PQ Bypass, Merit, and Sur-
Stradins Clinical University Hospital, University of Latvia, Riga; the Division of modics. K.O. and K.N. are employees of Syntactx, a clinical research organiza-
Vascular Surgery, Department of Cardiac and Vascular Surgery, Medical Uni- tion that received research funding from PQ Bypass and other manufacturers
versity of Gdansk, Gdanskb; the Department of Angiology, University Hospital of lower extremity interventional devices. K.O. has equity in Syntactx. A.S. is a
Leipzig, Leipzigc; the Department of Vascular Surgery, Institute of Hematolo- consultant for Abbott, Bard/BD, Cook, Cordis/Cardinal Health, Reflow Medi-
gy and Transfusion Medicine, Warsawe; the Department of Vascular and cal, and Upstream Peripheral.
Endovascular Surgery, Pontificia Universidad Católica de Chile, Santiagof; Presented in part at the 2018 Vascular Annual Meeting of the Society for
Syntactx, New Yorkg; and the Director of Interventional Radiology, Auckland Vascular Surgery, Boston, Mass, June 20-23, 2018.
City Hospital, Auckland,h Additional material for this article may be found online at www.jvascsurg.org.
The DETOUR I trial and the preparation of this manuscript were funded by PQ Correspondence: Dainis K. Krievins, MD, PhD, Professor of Vascular Surgery, P.
Bypass. Stradins University Hospital, 13 Pilsonu St, Riga, Latvia LV-1002 (e-mail:
ClinicalTrials.gov identifier: NCT02471638. dainis.krievins@gmail.com).
Author conflict of interest: D.S. is on the advisory board of and a consultant for The editors and reviewers of this article have no relevant financial relationships to
Abbott, Bayer, Boston Scientific, Cook Medical, Cardionovum, CR Bard, Gardia disclose per the JVS policy that requires reviewers to decline review of any
Medical/Allium, Medtronic, Philips, and Upstream Peripheral Technologies. manuscript for which they may have a conflict of interest.
A.K.‘s hospital received payments from PQ Bypass for expenses incurred dur- 0741-5214
ing admission and procedure, and the professional staff also received hono- Copyright Ó 2020 by the Society for Vascular Surgery. Published by Elsevier Inc.
raria; however, A.K. does not have an employment arrangement or royalty/ https://doi.org/10.1016/j.jvs.2020.02.043
stock agreement with PQ Bypass. A.H. is a clinical investigator and advisory
board member for Gore, Medtronic, and Boston Scientific as well as a clinical

1
2 Krievins et al Journal of Vascular Surgery
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endovascular treatment is recommended for less com-

plex TransAtlantic Inter-Society Consensus II3,4 (TASC II) ARTICLE HIGHLIGHTS
A or B lesions, there is no consensus for TASC II C and d
Type of Research: Multicenter, prospective, non-
D lesions.4 Treating long complex lesions endovascularly randomized study
can be challenging, with inferior patency rates and d
Key Findings: Seventy-eight patients with long-
frequent interventions, even with newer adjuncts such segment femoropopliteal lesions (average length of
as drug-eluting stents, drug-coated balloons (DCBs), 371 6 55 mm) were treated with the PQ Bypass
and atherectomy. Furthermore, long-lesion endovascular DETOUR System. Primary, assisted primary, and sec-
treatment often requires multiple devices, which in- ondary patency rates at 1 year were 81%, 82%, and
creases procedural costs and morbidity. Open surgical 90%, respectively. Freedom from major adverse
bypass is less dependent on length and remains the events was 84% at 1 year.
“gold standard” for treatment of challenging femoropo- d
Take Home Message: The PQ Bypass DETOUR Sys-
pliteal disease. Long-term patency rates of surgical tem is a safe and effective endovascular treatment
bypass are historically superior to those of endovascular option for patients with complex, long, and severely
options for more complex disease, but perioperative calcified femoropopliteal lesions.
complications can be frequent, particularly in medically
compromised patients with generalized atherosclerosis
prone to lower extremity arterial disease.5-7 index <0.7 were eligible. Patients had symptoms of sig-
The PQ Bypass DETOUR System (PQ Bypass, Milpitas, nificant claudication, rest pain, or ischemic ulceration,
Calif) was developed as a less invasive alternative to but those with tissue loss extending proximal to the toes
open surgical bypass for above-knee long-segment were excluded. Screening procedures included deep
femoropopliteal lesions. The system uses a percuta- vein duplex ultrasound to assess vein diameter and
neous approach to deploy a covered stent graft from either computed tomography angiography or magnetic
the superficial femoral artery (SFA) proximally to the resonance angiography. Femoropopliteal target lesions
popliteal artery distally. The stent graft is deployed were $100 mm in length and could include diffuse ste-
through a transvenous route that allows venous blood notic disease, chronic total occlusions, or in-stent reste-
to flow around the device. Bypassing complex femoro- nosis. Iliac and femoral arteries and veins needed to be
popliteal disease offers the opportunity to emulate suitable for endovascular access and device delivery in
open surgical bypass outcomes while reducing compli- the investigator’s opinion. Patients needed to have a
cations with a totally percutaneous approach. The patent popliteal artery 3 cm proximal to the tibial
DETOUR I trial is the first study to assess the safety plateau.
and effectiveness of the DETOUR system. Herein, we Patients with a history of comorbidities including
report the 1-year outcomes in patients treated with deep venous thrombosis (DVT), dialysis-dependent
the DETOUR system for percutaneous femoropopliteal renal failure, dementia, congestive heart failure,
bypass. chronic obstructive pulmonary disease, and metastatic
malignant disease were excluded. In addition, patients
METHODS were excluded if they had undergone previous bypass
Study design. The prospective, single-arm, multicenter, surgery of the target limb or target limb revasculariza-
international, premarket DETOUR I trial examined the tion within 7 days of the index procedure. Patients
safety and effectiveness of the PQ Bypass System in the could not be included if they underwent coronary
treatment of long-segment femoropopliteal disease. intervention within 30 days of treatment or underwent
During a 24-month period, 78 patients were enrolled at 8 thrombolysis within 72 hours of treatment where
investigational sites. Follow-up visits were scheduled at thrombus resolution was not achieved. Patients were
1 month, 3 months, and 6 months and then every also excluded if they were on dialysis or were
6 months through 24 or 36 months, depending on a receiving immunosuppressant therapy in the 30 days
country-specific protocol. Visit assessments included before the index procedure. The Supplementary
Rutherford class; ankle-brachial index (ABI); lower ex- Table (online only) lists all inclusion and exclusion
tremity arterial and venous duplex ultrasound imaging; criteria.
and venous quality of life measures, namely, the Venous The study was approved by the institutional ethics
Clinical Severity Score (VCSS) and Villalta score. Adverse committee, and all patients signed informed consent.
events were recorded when sites became aware of an
Device and procedure description. The DETOUR Sys-
event or at each visit.
tem consists of the PQ Snare, PQ Crossing Device, and
Patient eligibility. Patients aged 18 to 90 years with a TORUS Stent Graft (Fig 1). The PQ Snare is a dual-
body mass index <40 kg/m2 and resting ABI <0.9 or, in caged scaffold and snare intended for vessel support
those with incompressible vessels, a toe-brachial and guidewire delivery. The PQ Crossing Device
Journal of Vascular Surgery Krievins et al 3
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employs a nitinol needle for arteriovenous crossing and A series of TORUS stent grafts, typically two or three, are
delivery of a 0.014-inch guidewire. The TORUS Stent deployed from the popliteal artery, through the distal
Graft system is a self-expanding nitinol wire frame anastomosis and the femoral vein, and re-enter the ar-
encapsulated in expanded polytetrafluoroethylene. The tery through the proximal anastomosis. This results in a
delivery catheter is an over-the-wire 8F system with a functional end-to-end anastomosis as opposed to an
1350-mm working length compatible with a 0.035-inch end-to-side anastomosis, thereby limiting retrograde
guidewire. flow. The last stent graft is deployed with its end just
The procedure, depicted in Fig 2, begins with contralat- above the ostium of the SFA. The stents are oversized
eral common femoral artery access using a 0.35-inch to 0% to 10% of the arterial diameter and must have a
platform and 8F crossover sheath, which is later 6-cm overlap with the adjacent stent. The stent grafts
exchanged for a 0.014-inch guidewire that is threaded are postdilated as necessary, completion angiography is
into the vasculature. Ipsilateral posterior tibial vein access performed (Fig 3), and the sheaths and guidewires are
is gained using ultrasound guidance, and a second removed.
0.014-inch guidewire is placed into the femoral vein. Heparin and dual antiplatelet therapy were adminis-
The snare is advanced over the venous guidewire, and tered during the procedure and during the course of
the distal snare cage is positioned just above the prox- the study, respectively.
imal aspect of the SFA occlusion. The two snare cages
Study administration. An independent core labora-
are then expanded in the femoral vein.
tory (Cleveland Clinic, Cleveland, Ohio) assessed
The crossing device is advanced over the arterial guide-
computed tomography angiography, duplex ultra-
wire and positioned proximal to the SFA occlusion. To
sound, and plain film radiography images. The imaging
create the proximal anastomosis, fluoroscopy guidance
data presented are core laboratory reported unless
is used to rotate the crossing device’s flag, so it points to-
otherwise specified. An independent Medical Monitor
ward the femoral vein. Next, the crossing device needle is
(Syntactx, New York, NY), a licensed physician, and a
deployed through the wall of the artery, into the venous
certified MedDRA coder reviewed each adverse event
lumen, and through the interstices of the distal snare
to determine whether adjudication was necessary. An
cage. After a 0.014-inch guidewire is advanced through
independent Clinical Events Committee (Syntactx)
the needle and into the distal snare cage, the needle is
adjudicated the safety end points, including compo-
retracted. The guidewire is snared and the sheath is
nents of the composite outcomes of major adverse
advanced over both cages, then the snare and guidewire
events (MAEs) and major adverse vascular events
are withdrawn from the body, leaving the 0.014-inch
(MAVEs). An independent Medical Monitor (Syntactx)
guidewire with through-and-through access from the
determined whether revascularization procedures
contralateral femoral artery access site to the posterior
met the definition of clinically driven target vessel
tibial vein access sites. The proximal anastomosis is
revascularization (CD-TVR).
dilated using a 4
20-mm angioplasty balloon (Cordis,
Hialeah, Fla). Outcome measures. The primary safety outcome was
The distal anastomosis is created in a similar fashion, the 1-month MAE rate, defined as a composite end
advancing the PQ Snare over the 0.014-inch guidewire point of death, CD-TVR, or major target limb amputation.
to a level in the vein just below the arterial occlusion The primary effectiveness end point was 6-month
but above the tibial plateau, followed by expansion of patency based on duplex ultrasound with a systolic ve-
the cages. The crossing device is advanced through the locity exceeding 2.5 and defined as freedom from oc-
proximal anastomosis and into the femoral vein, docking clusion, $50% diameter stent graft stenosis, or CD-TVR.
the crossing device with the PQ Snare. Under fluoroscopy CD-TVR was defined by revascularization in a target
guidance, the needle is extended through the venous vessel with core laboratory-reported occlusion or reste-
wall into the adjacent artery below the occlusion. A sec- nosis $50% and ipsilateral symptoms referable to the
ond 0.014-inch guidewire is advanced through the lesion.8
crossing device and into the popliteal artery distal to Secondary safety end points included the overall MAE
the occlusion. The crossing device is removed, leaving rate, the rate of MAVEs, stent fractures, symptomatic
the 0.014-inch guidewire in place, with the guidewire target DVT, major target limb amputation, and changes
bridging from the artery, through the proximal anasto- in VCSS and Villalta score. MAVEs included stent graft
mosis and the femoral vein, and into the artery below thrombosis, target limb amputation, clinically apparent
the occlusion. After the distal anastomosis is dilated distal embolization with tissue loss, procedure-related
with a 4
20-mm balloon, the 0.014-inch guidewire is arterial rupture, acute limb ischemia, and bleeding
exchanged over a catheter for a stiffer 0.035-inch events requiring any transfusion. Major bleeding required
guidewire. blood transfusion >2 units.
4 Krievins et al Journal of Vascular Surgery
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Fig 1. Components of the PQ Bypass DETOUR I System. The system is composed of the (A) PQ Crossing Device, (B)
PQ Snare, and (C) TORUS Stent Graft. D, The completed procedure redirects arterial blood flow around a long
femoropopliteal blockage.

Fig 2. The PQ Bypass DETOUR procedure. Step by step illustration depicting the endovascular femoral artery
bypass starting with the venous and arterial access and ending with the deployment of the TORUS grafts.
Journal of Vascular Surgery Krievins et al 5
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Fig 3. Angiography images before and after the DETOUR procedure. A, Superficial femoral artery (SFA) occlusion
with a small stump. B, Popliteal artery reconstitution. C, Completion angiography of the proximal part of the graft.
The “proximal anastomosis” (transition) between the artery and the vein is visible as a slight kink. D, Completion
angiography of the distal part of the bypass with the “distal anastomosis” visible.

Secondary effectiveness end points included technical, through 1 month and 6 months after the index proced-
procedural, and clinical success. Technical success was ure, respectively. Continuous variables are expressed as
the successful delivery of the device and removal of the mean 6 standard deviation. Categorical variables are
delivery system. Procedural success was defined as tech- expressed as the number of events divided by the num-
nical success without MAEs through the conclusion of ber of observations. Primary safety and effectiveness end
the procedure. Clinical success was defined at each points are specified with 95% one-sided exact (Clopper-
follow-up time point as improvement in the Rutherford Pearson) confidence intervals (CIs). Kaplan-Meier meth-
class compared with baseline. Other secondary effective- odology (estimate 6 standard error) was used for
ness measures included protocol-defined primary, pri- patency (primary, primary assisted, and secondary) and
mary assisted, and secondary patency; ABI; CD-TVR; freedom from CD-TVR, MAE, MAVE, and stent throm-
and freedom from major amputation. The protocol bosis. SAS version 9.4 software (SAS Institute, Cary, NC)
defines primary assisted and secondary patency as a was used for statistical analyses.
revascularization of a nonocclusive or occlusive stenosis,
RESULTS
respectively, within the stent graft or immediately above
Demographic and baseline characteristics. The intent-
or below the treated segment with <50% residual
to-treat cohort comprised 78 patients with 82 treated
stenosis.
limbs (Table I). The procedure was not completed in
Statistical analysis. The DETOUR I trial was designed as 1 patient, leaving 77 patients and 81 lesions in the per
a descriptive study with no formal hypothesis testing; protocol cohort; however, the per protocol cohort will not
however, a sample size calculation was performed using be considered further. The mean age of the 78 patients
a 70% protocol-specified performance goal for the pri- was 65 6 7 years, and 65 (83%) were men. Comorbidities
mary effectiveness end point of 6-month stent graft generally paralleled other lower extremity interventional
patency. The performance goal was based on literature- trials, with a history of smoking in 68 of 78 patients (87%),
derived rate of 80% and a 10% margin.9-14 Using an hypertension in 65 (83%), coronary artery disease in
anticipated 85% rate for the primary effectiveness end 34 (44%), and diabetes in 20 (26%).
point based on early investigations, a 60-patient sample The mean ABI was 0.64 6 0.17 at baseline (Table I). The
size provided 80% power with a one-sided a level of .05 average pretreatment target lesion length was
to detect a difference compared with the performance 371 6 55 mm (normal to normal length, core laboratory
goal, allowing attrition of 10 patients during 6 months. preprocedure computed tomography imaging), and all
For the purposes of the current evaluation, all analyses but three of the lesions (79/82 [96%]) were chronic total
were performed on an intent-to-treat basis. The primary occlusions with an average occlusion length of
safety and effectiveness end points were defined 159 6 88 mm. Of the 82 limbs, 76 (93%) were assigned
6 Krievins et al Journal of Vascular Surgery
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Table I. Demographic and baseline characteristics appropriate. The final procedural result was satisfactory
Patient characteristics in the two limbs. The procedure was unable to be
Age, years (n ¼ 78) 65 6 7 completed in the third limb for which two needle sys-
Men 65/78 (83) tems were not effective and additional devices were
Comorbidities
not available. The average length of stay from procedure
to discharge was 2.0 6 1.4 days. Clinical success was
Hypertension 65/78 (83)
achieved in 76 of 81 limbs (94%) at 1 month after the pro-
Diabetes mellitus 20/78 (26)
cedure (Table II).
Hypercholesterolemia 31/78 (40)
The 1-month rate of freedom from MAE was 98% (79/81
History of CAD 34/78 (44) limbs; 95% CI, 92%-99.6%). There were two CD-TVRs (2/81
History of smoking 68/78 (87) [2%]) performed on postoperative days 6 and 29 for stent
Previous peripheral vascular 19/78 (24) graft thrombosis (Table III). Freedom from MAVE was 95%
intervention (77/81 limbs), with three stent graft thromboses (two
Lesion characteristics treated) and one bleeding episode with a 2-unit transfu-
SFA lesion length, mm (n ¼ 82) 371 6 55 sion for bleeding at the posterior tibial vein access site.
ABI (n ¼ 82) 0.64 6 0.17 Through the 1-month follow-up, an ipsilateral DVT
TASC lesion type developed in one patient (1%). By 1 month, 60 of 81 limbs
C 46/82 (56) (74%) were symptom free (Rutherford class 0), and 14 of
D 36/82 (44) 81 (17%) had symptoms limited to mild claudication
Chronic total occlusion 79/82 (96) (Rutherford class 1; Table II). The mean 1-month ABI
Rutherford class
was 0.94 6 0.20, an increase of 0.29 6 0.24 compared
with the baseline ABI (P < .001).
3 76/82 (93)
4 5/82 (6) Midterm outcomes. MAEs occurred in 7 of 81 limbs
5 1/82 (1) (9%) through 6 months and in 13 of 80 limbs (16%)
Calcification through 1 year (Table III). The Kaplan-Meier estimates of
Mild 15/82 (18) freedom from MAE were 91% 6 3% at 6 months and
Moderate 11/82 (13) 84% 6 4% at 1 year (Fig 4). Freedom from MAVEs was
Severe 55/82 (67)
estimated to be 89% 6 4% at 6 months and 83% 6 4% at
1 year (Fig 4). There was one death through 1 year (1%),
Runoff vesselsa
occurring on postprocedure day 113 after an ischemic
1 6/78 (8)
stroke treated with thrombolysis and complicated by
2 23/78 (30)
fatal hemorrhagic transformation. No patient had a
3 49/78 (63) major index limb amputation and no stent fractures
ABI, Ankle-brachial index; CAD, coronary artery disease; SFA, superficial through 1 year.
femoral artery; TASC, TransAtlantic Inter-Society Consensus (version II).
Categorical variables are presented as n/N (%). Continuous variables The primary effectiveness end point of 6-month pri-
are presented as mean 6 standard deviation. mary patency was 72 of 81 (89%; 95% CI, 81%-94%);
a
There were four limbs without core laboratory assessment of runoff
status. thus, the primary effectiveness end point was met with
the lower limit of the 95% CI >70% performance goal.
Among the nine primary effectiveness end point failures
through 6 months, there were five stent graft stenoses
to Rutherford class 3 at baseline. There were no TASC A
>50% diameter reduction (three with CD-TVRs) and
or B lesions; 46 of 82 lesions (56%) were TASC C, and 36
four stent graft thromboses (three with CD-TVRs). In all,
of 82 (44%) were TASC D. The core laboratory graded
there were six CD-TVRs through 6 months.
arterial calcification as severe in 55 of 82 limbs (67%).
The Kaplan-Meier estimate of primary patency was
There were three runoff vessels in 49 of 78 limbs (63%)
89% 6 4% at 6 months and 81% 6 4% at 1 year (Fig 5).
with core laboratory assessment of outflow.
The corresponding 6-month and 1-year estimates were
Periprocedural outcomes. Technical success and pro- 89% 6 4% and 82% 6 4% for assisted primary patency
cedural success were both achieved in 79 of 82 limbs and 94% 6 3% and 90% 6 3% for secondary patency,
(96%). The investigators reported three limbs with unsat- respectively. Freedom from CD-TVR was 93% 6 3% at
isfactory delivery and deployment of the device. In one 6 months and 85% 6 4% at 1 year (Kaplan-Meier esti-
case, there was inadequate overlapping between stent mates, Fig 6), with 12 CD-TVRs (12/79 [15%]) through the
grafts and an inadequate distal landing zone during first year after the index procedure. Among the
the procedure. Another patient had a bilateral DETOUR CD-TVRs, 7 of 12 (58%) were open surgical procedures
procedure in which the proximal edge of the proximal (bypass in 5, thrombectomy in 1) and 5 of 12 (42%) were
stent graft was placed more distally than deemed endovascular interventions (4 limbs with DCB
Journal of Vascular Surgery Krievins et al 7
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Table II. Effectiveness outcomes

1 month 3 months 6 months 1 year
Clinical success 76/81 (93.8) 82/82 (100.0) 77/81 (95.1) 77/80 (96.3)
Rutherford-Becker classification
0. Asymptomatic 60/81 (74.1) 67/82 (81.7) 67/81 (82.7) 65/80 (81.3)
1. Mild claudication 14/81 (17.3) 12/82 (14.6) 8/81 (9.9) 8/80 (10.0)
2. Moderate claudication 2/81 (2.5) 2/82 (2.4) 2/81 (2.5) 4/80 (5.0)
3. Severe claudication 2/81 (2.5) 0/82 (0.0) 3/81 (3.7) 2/80 (2.5)
4. Ischemic rest pain 2/81 (2.5) 0/82 (0.0) 1/81 (1.2) 0/80 (0.0)
5. Minor tissue loss 1/81 (1.2) 0/82 (0.0) 0/81 (0.0) 1/80 (1.3)
6. Major tissue loss 0/81 (0.0) 0/82 (0.0) 0/81 (0.0) 0/80 (0.0)
ABI 0.94 6 0.20 0.94 6 0.22 0.93 6 0.24 0.90 6 0.20
ABI, Ankle-brachial index.
Values are reported as n/N (%). The denominators reflect the number of limbs with entries for the given follow-up period.
Clinical success: limb ischemia improvement by Rutherford-Becker classification (improvement in scale by $1) through follow-up.

Table III. Safety outcomes

1 month 3 months 6 months 1 year
MAEs 2/81 (2.5) 4/81 (4.9) 7/81 (8.6) 13/80 (16.3)
Death 0/81 (0.0) 0/81 (0.0) 1/80 (1.3) 1/79 (1.3)
CD-TVR 2/81 (2.5) 4/81 (4.9) 6/80 (7.5) 12/79 (15.2)
Target limb amputation 0/81 (0.0) 0/81 (0.0) 0/80 (0.0) 0/79 (0.0)
MAVEs 4/81 (4.9) 7/81 (8.6) 9/80 (11.3) 14/79 (17.7)
Stent thrombosis 3/81 (3.7) 6/81 (7.4) 8/80 (10.0) 13/79 (16.5)
Clinically apparent distal embolization 0/81 (0.0) 0/81 (0.0) 0/80 (0.0) 0/79 (0.0)
Procedure-related arterial rupture 0/81 (0.0) 0/81 (0.0) 0/80 (0.0) 0/79 (0.0)
Acute limb ischemia 0/81 (0.0) 0/81 (0.0) 0/80 (0.0) 0/79 (0.0)
Bleeding event requiring transfusion 1/81 (1.2) 1/81 (1.2) 1/80 (1.3) 1/79 (1.3)
DVT in target limb 1/81 (1.2) 1/81 (1.2) 2/80 (2.5) 2/79 (2.5)
VCSS 1.1 6 1.6 0.8 6 1.3 0.8 6 1.2 0.8 6 1.4
Villalta score 0.4 6 0.9 0.8 6 1.7 0.5 6 1.0 0.5 6 1.1
Stent fracture 0/81 (0.0) 0/81 (0.0) 0/80 (0.0) 0/79 (0.0)
DVT, Deep venous thrombosis; MAEs, major adverse events; MAVEs, major adverse vascular events; VCSS, Venous Clinical Severity Score.
Values are reported as n/N (%). The denominator at each time point is equal to the number of limbs (lesions) that reached the lower limit of the follow-
up window plus the number of limbs that experienced an event and did not reach the lower limit of the follow-up window.
MAVE through follow-up is defined as stent thrombosis, target limb amputation, clinically apparent distal embolization (defined as causing end-
organ damage, eg, lower extremity ulceration, tissue necrosis, or gangrene), procedure-related arterial rupture, acute limb ischemia, or bleeding
event requiring transfusion.

angioplasty in 5, stent placement in 2, mechanical asymptomatic, and 8 of 80 (10%) had mild claudication
thrombectomy in 1). There were 8 stent graft thromboses (P < .001 vs baseline).
through 6 months (10%) and 13 through 1 year (13/79 Venous status. DVT occurred in 2 of 79 target limbs
[17%]), accounting for a 90% 6 3% Kaplan-Meier esti- (3%) through 1 year (Table III), and both involved the
mate of freedom from stent graft thrombosis at 6 months femoral and popliteal veins, one presenting at 27 days
and 84% 6 4% through 1 year (Fig 6). and the other at 178 days after the procedure. The veins
The ABI was 0.93 6 0.24 at 6 months (P < .001 vs base- were patent immediately after the index procedure in
line) and 0.90 6 0.20 at 1 year (P < .001 vs baseline; both patients. Thrombotic occlusion of the popliteal vein
Table II). At 6 months, the Rutherford class improved and of the middle and distal thirds of the femoral vein
from baseline in 77 of 81 limbs, 67 of 81 (83%) were was identified in one patient at 1 month. Occlusive
asymptomatic, and 8 of 81 (10%) had mild claudication thrombus of the distal femoral and popliteal vein was
(P < .001 vs baseline). At 1 year, the Rutherford class identified at the 6-month follow-up. By the 1-year
improved in 77 of 80 limbs (96%), 65 of 80 (81%) were follow-up, the patient had nonocclusive thrombus at
8 Krievins et al Journal of Vascular Surgery
--- 2020

laboratory-determined mean lesion length of 371 mm,

chronic total occlusions in 96%, and severe calcification
in 67% of patients, 81% 1-year protocol-defined primary
patency rate was achieved, with no major amputations
and a 15% 1-year CD-TVR rate. Many of the failed stent
grafts could be remediated with reinterventions, evi-
denced by a 90% 1-year secondary patency rate.
Treatment of femoropopliteal arterial disease historical-
ly involved autogenous vein or prosthetic graft open sur-
gical bypass. The first saphenous vein bypass was
reported by Kunlin in 1948, at a time when the treatment
of lower extremity arterial disease was limited to lumbar
sympathectomy or, for localized lesions, endarterec-
tomy.15 Thereafter, open surgical bypass became a main-
stay for treatment of femoropopliteal and tibial occlusive
disease, with durable long-term patency rates.7 The
morbidity of the procedure, however, is significant in
the commonly encountered medically compromised
patient with lower extremity arterial disease who often
presents with multiple comorbidities because of
advanced age, generalized atherosclerosis, smoking his-
tory, and diabetic prevalence. There are economic limita-
tions of open surgical bypass; the lengths of hospital stay
are longer compared with endovascular interventions,
and wound complications occur in 11% of cases within
30 days after the procedure.16 The DETOUR procedure,
as a purely endovascular intervention, reduces the op-
portunity for wound complications. This may play a role
in reducing surgical site infection rates, which can have
Fig 4. Kaplan-Meier estimates of freedom from major
adverse event (MAE) and major adverse vascular event an impact on patient outcomes and hospital lengths of
(MAVE). At 1 year, the freedom from MAE and MAVE was stay.17-19
estimated to be 84% 6 4% and 83% 6 4%, respectively. On this landscape, endovascular interventions for lower
extremity PAD burgeoned. Initially, percutaneous
balloon angioplasty was the only option, and long-term
the popliteal vein. Both patients were treated with anti- results were poor, particularly with lesion lengths
coagulant therapy. No patient experienced pulmonary >100 mm.20 Newer devices and techniques were devel-
embolism. oped to improve patency, including stents, atherectomy
Overall, there were no significant changes in the VCSS devices, and lasers.2 More recently, the use of covered
or Villalta score during follow-up, averaging near zero at stents, drug-eluting stents, and DCBs was investigated,
all time points. The mean VCSS was 0.6 6 1.0 at baseline and many are now available in the marketplace.21-24
compared with 0.8 6 1.2 and 0.8 6 1.4 at 6 and 12 months, DCBs have shown promise for treating long lesions but
respectively. Corresponding values for the mean Villalta have limited success in heavily calcified lesions.25
score were 0.4 6 0.9 at baseline and 0.5 6 1.0 and Furthermore, a systematic review and meta-analysis
0.5 6 1.1 at 6 and 12 months, respectively. The patient pre- found increased all-cause mortality risk with paclitaxel,
senting with a DVT at 27 days had a VCSS of 2 at 1 month, the active pharmaceutical agent in most DCBs, although
0 at 6 months, and 3 at 12 months, with corresponding the biologic plausibility of this finding remains elusive.26
Villalta scores of 2, 0, and 0. The patient with a DVT at Last, provisional stenting may still be required in as
178 days had VCSS and Villalta score of 1 at all time many as 25% of chronic total occlusions because of resid-
points. ual stenosis or dissection after DCB angioplasty alone.23
Endovascular treatment of femoropopliteal lesions
DISCUSSION >150 mm in length results in 1-year patency rates be-
The DETOUR I trial confirmed the short-term safety and tween 50% and 60%.27 These results must be considered
effectiveness of the fully percutaneous PQ Bypass in the context of a small number of study patients with
DETOUR System for endovascular femoropopliteal severe calcification and lesion lengths >250 mm. As
bypass in patients with complex long-segment well, few chronic total occlusions were enrolled in
femoropopliteal occlusive disease. With a core many of these studies. Based in part on these data, the
Journal of Vascular Surgery Krievins et al 9
Volume -, Number -

for Vascular Surgery guidance, recommending endovas-

cular therapy for lesions <250 mm in length and noting
that outcome is superior with open surgical bypass for
longer lesions.29
The DETOUR device was designed to emulate the re-
sults of surgical femoropopliteal bypass, without some
of the limitations of traditional endovascular interven-
tions and, potentially, with improved durability. The
DETOUR I trial is probably one of the largest prospec-
tive, core laboratory-adjudicated series studying
the endovascular treatment of lesions averaging
>250 mm in length. The 1-year results confirmed the
safety of the device. Despite a challenging population
of patients with average lesion lengths of 371 mm and
severe calcification in two-thirds of the lesions, out-
comes were favorable. MAEs were limited to CD-TVRs
in 3% of treated lesions through 1-month follow-up.
Other vascular events were uncommon, with a 1-
month MAVE rate of 5%. The potential concern of using
a transvenous route for the stent grafts appeared to be
of less concern, with a complete absence of pulmonary
embolism and a 3% risk of ipsilateral DVT through
1 year, only modestly elevated above the rates reported
after open surgical revascularization.30 Symptoms of
venous outflow obstruction were not evident after the
procedure, without worsening of the VCSS or Villalta
indices.
The DETOUR System effectively remediated claudica-
tion symptoms. Rutherford class improved in 96% of pa-
tients at 1 year. Hemodynamically, the procedure
resulted in ABI normalization, a benefit that persisted
through 1 year. Short-term patency was promising,
particularly considering the complexity of the treated le-
sions. Rates of reintervention were similarly encouraging
with stent graft occlusions comparable to or improved
over those observed after other open surgical or interven-
tional treatment for long femoropopliteal lesions.31,32 The
observations suggest that regular imaging follow-up
with duplex ultrasound can detect treatable restenosis
before thrombosis, and even when thrombosis does
occur, reconstitution of patency is possible.
The DETOUR I trial must be considered within the
Fig 5. Kaplan-Meier estimates of patency. The 1-year esti- context of some limitations of this first multicenter eval-
mates of primary, assisted primary, and secondary patency uation of the DETOUR System. The trial was limited by
were 81% 6 4%, 82% 6 4%, and 90% 6 3%, respectively. the relatively small sample size and the currently avail-
able 1-year length of follow-up. Furthermore, as a
single-arm trial, DETOUR I has the limitations of any non-
Society for Vascular Surgery Practice Guidelines included randomized study. Comparisons with other therapies are
a Level 1, Grade B recommendation for open surgical limited to data reported in the literature, data generated
bypass as the initial treatment option for claudicants from studies that may have a distinctly different popula-
with diffuse femoropopliteal disease, extensive arterial tion of patients.
calcification, or small-caliber arteries.28 However, an addi-
tional guideline proviso suggests that surgical bypass CONCLUSIONS
should be limited to claudicants of average or low oper- The PQ Bypass DETOUR System provides a safe and
ative risk. A newer document published by a joint task effective percutaneous solution for patients with com-
force reiterated the recommendations of the Society plex long-segment femoropopliteal disease because it
10 Krievins et al Journal of Vascular Surgery
--- 2020

AUTHOR CONTRIBUTIONS
Conception and design: DK, GH, DS, JS, PS, AK, AH, AS
Analysis and interpretation: KO, KN
Data collection: DK, GH, DS, JS, PS, AK, AH, AS
Writing the article: KO, KN
Critical revision of the article: DK, GH, DS, JS, PS, AK, KO,
KN, AH, AS
Final approval of the article: DK, GH, DS, JS, PS, AK, KO,
KN, AH, AS
Statistical analysis: KO, KN
Obtained funding: Not applicable
Overall responsibility: DK
DK and GH participated equally and share first
authorship.

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11.e1 Krievins et al Journal of Vascular Surgery
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Supplementary Table (online only). DETOUR I study entry criteria

Inclusion criteria
1. Age 18 years or older.
2. Willing to comply with the specified follow-up evaluation schedule.
3. Women of childbearing potential must have a negative pregnancy test result within 7 days before the index procedure.
4. Severe claudication or rest pain or ischemic ulceration not exceeding ulcer of the digits of the foot (Rutherford-Becker scale 3-5)
with a resting ABI <0.9. Resting TBI is used only if unable to reliably assess ABI. TBI must be <0.7.
5. Patient is not morbidly obese (body mass index <40 kg/m2).
6. Venous Clinical Severity Score <3.
7. Serum creatinine level < 2.0 mg/dL.
8. BUN <20 mg/dL.
9. Patent iliac and femoral arteries/veins and access vessels, of sufficient size and morphology (including tortuosity), to allow
endovascular access with 8F introducer sheath.
10. Femoropopliteal lesions $10 cm (TASC C and D) in length considered to be:
a Chronic total occlusion (100% stenosis)
b Diffuse stenosis (>50% stenosis) with moderate to heavy calcification
c In-stent restenosis (>50% stenosis)
11. Reference vessel diameter $5.0 mm and #6.7 mm, as measured by prescreening CTA or MRA using three-dimensional
multiplanar reconstruction.
12. Orifice and proximal 1 cm of SFA is patent (approximately 1-cm stump).
13. Patent popliteal artery 3 cm proximal to tibial plateau.
14. At least one patent tibial artery to the foot.
15. Patient has the ability to comply with the necessary follow-up examinations and tests in accordance
with protocol.
16. Patent femoral vein $10 mm in diameter or duplicate femoral vein.
17. Patient has >2-year life expectancy.
Exclusion criteria
1. Age >90 years.
2. History of deep venous thrombosis.
3. Patient has known hypersensitivities, allergies, or contraindications to nitinol, polytetrafluoroethylene; aspirin, heparin,
antiplatelet, anticoagulant, or thrombolytic therapy; or anticoagulation or contrast media.
4. Patient has a known history of intracranial bleeding or aneurysm, myocardial infarction, or stroke within
the last 3 months.
5. Pregnant or nursing.
6. Untreated flow-limiting aortoiliac occlusive disease.
7. Patient has renal failure (eGFR <30 mL/min).
8. Major distal amputation (above the transmetatarsal) in the study or nonstudy limb.
9. Patient has had a revascularization procedure on the target limb within 7 days of the planned
index procedure.
10. Known or suspected active infection at the time of the procedure.
11. Patient requires a coronary intervention #30 days before or 30 days after treatment of the
target lesion.
12. Thrombophlebitis within the previous 30 days.
13. Thrombolysis of the target vessel within 72 hours before the index procedure, where complete resolution of the thrombus was
not achieved.
14. Receiving dialysis or immunosuppressant therapy within the previous 30 days.
15. Stroke within the previous 90 days.
16. Ipsilateral femoral aneurysm or aneurysm in the SFA or popliteal artery.
17. Planned amputation of the target limb.
18. Previous bypass surgery on the target limb.
19. Participating in another clinical study for which follow-up is currently ongoing, which may have an impact on the current
study.
Journal of Vascular Surgery Krievins et al 11.e2
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Supplementary Table (online only). Continued.

20. Congestive heart failure, COPD (stage IV, FEV1 <30% normal, or <50% normal with chronic respiratory failure present),
metastatic malignant disease, dementia, or other major comorbidities that would prevent the
postinterventional movement.
21. A condition that in the view of the investigator precludes participation in this study.
ABI, Ankle-brachial index; BUN, blood urea nitrogen; COPD, chronic obstructive pulmonary disease; CTA, computed tomography angiography; eGFR,
estimated glomerular filtration; FEV1, forced expiratory volume in 1 second; MRA, magnetic resonance angiography; SFA, superficial femoral artery;
TASC, TransAtlantic Inter-Society Consensus; TBI, toe-brachial index.