DETOUR I Clinical Study for Percutaneous Femoropopliteal Bypass

NCT02471638 | Completed Results DMC FDA Device

• 1 other identifier: STP 115
• Study Type: interventional
• Target: 78
• Locations: 6 countries
• Sites: 8

Brief Summary

To assess the safety and performance of the PQ Bypass System to access, deliver guidewires and implant stent grafts for a percutaneous fem-pop bypass.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (2)

• Number of Lesions With Primary Patency

  Rate of primary patency. Primary patency defined as: no evidence of clinically significant stenosis (≥50%) within the stent graft or immediately above or below the treated arterial segment based on duplex ultrasound (systolic velocity ratio of \>2.5).

  6 Months

• Number of Lesions With Any Major Adverse Event (MAE) at One Month Post-procedure

  composite endpoint of death, CD-TVR, or major target limb amputation in all patients at One-month post procedure

  One Month

Secondary Outcomes (7)

• Number of Lesions With Each Major Adverse Event (MAE) at One Month Post-procedure

  One Month

• Percentage of Lesions With Primary Patency at 12 Months Post-Procedure

  12 Months

• Major Adverse Vascular Event (MAVE) Rate

  One Month

• Number of Lesions With Symptomatic Deep Vein Thromboses in Target Limb

  One Month

• Number of Major Adverse Events at the 12-Month Time Point

  12 Months

Study Arms (1)

Single arm study

EXPERIMENTAL

PQ Bypass System for Femoropopliteal Bypass to complete percutaneous fem-pop bypass

Device: PQ Bypass System for Femoropopliteal Bypass

Interventions

PQ Bypass System for Femoropopliteal Bypass DEVICE

To access, deliver guidewires and implant stent grafts for a percutaneous fem-pop bypass.

Single arm study

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to provide informed consent
• Age 18 or older
• Rutherford Classification of 3-5
• Patent iliac and femoral arteries/veins and access vessels, of sufficient size and morphology (including tortuosity), to allow endovascular access with 8 Fr. introducer sheath
• Femoro-popliteal lesions ≥10 cm in length considered to be:
• Chronic total occlusion (100% stenosis)
• Diffuse stenosis (\>50% stenosis) with moderate to heavy calcification
• In-stent restenosis (\>50% stenosis)
• Proximal and distal target vessels are 5.4-7.0 mm in diameter
• Orifice and proximal 1 cm of SFA is patent
• Patent popliteal artery 3 cm proximal to tibial plateau
• At least 1 patent tibial artery to the foot
• Patent femoral vein ≥ 10 mm in diameter or duplicate femoral vein
• Subject has \> one year life expectancy

You may not qualify if:

• Bypass length required \> 30 cm
• History of deep vein thrombosis
• Has a known hypersensitivities, allergies or contraindications to: nitinol, PTFE; aspirin, heparin, antiplatelet, anticoagulant or thrombolytic therapy; or anticoagulation or contrast media that is not amenable to pre-treatment;
• Has a known history of intracranial bleeding or aneurysm, myocardial infarction or stroke within the last 12 months
• Pregnant or nursing
• Untreated flow-limiting aortoiliac occlusive disease
• Has renal failure (eGFR \< 30mL/min)
• Major distal amputation (above the transmetatarsal) in the study or non-study limb
• Patient has had a revascularization procedure on the target limb within 30 days
• Patient has a planned amputation of the target limb
• Previous bypass surgery on the target limb
• Patient is participating in another clinical study for which follow-up is currently on going.
• Patient has a condition that in the view of the investigator precludes participation in this study

Sponsors & Collaborators

• Endologix: lead

Study Sites (8)

Universidad Católica de Chile

Santiago, Chile

Location

University of Leipzig Medical Centre

Leipzig, 04103, Germany

Location

Ospedale San Raffaele

Milan, 20132, Italy

Location

Stradins University Hospital

Riga, LV-1002, Latvia

Location

Vascular Service

Auckland, 1023, New Zealand

Location

Gdansk Medical University

Gdansk, Poland

Location

Poznan University of Medical Sciences

Poznan, 61-848, Poland

Location

Institute of Haematology Medicine Indira Gandhi

Warsaw, Poland

Location

Related Publications (2)

• Schneider PA, Krievins DK, Halena G, Schmidt A, Lyden S, Lee V, Hu M, Adelman M. Venous outcomes at 1 year after using the femoral vein as a conduit for passage of percutaneous femoropopliteal bypass. J Vasc Surg Venous Lymphat Disord. 2021 Sep;9(5):1266-1272.e3. doi: 10.1016/j.jvsv.2020.12.080. Epub 2021 Jan 8.

  PMID: 33429092 DERIVED

• Krievins DK, Halena G, Scheinert D, Savlovskis J, Szopinski P, Kramer A, Ouriel K, Nair K, Holden A, Schmidt A. One-year results from the DETOUR I trial of the PQ Bypass DETOUR System for percutaneous femoropopliteal bypass. J Vasc Surg. 2020 Nov;72(5):1648-1658.e2. doi: 10.1016/j.jvs.2020.02.043. Epub 2020 Apr 8.

  PMID: 32276015 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Results Point of Contact

• Title: Tammy Stiver
• Organization: Endologix

tstiver@endologix.com

5136731452

Study Officials

• Dierk Scheinert, PhD

  University of Leipzig

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2015
• First Posted: June 15, 2015
• Study Start: January 1, 2015
• Primary Completion: September 1, 2018
• Study Completion: June 1, 2020
• Last Updated: May 23, 2025
• Results First Posted: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

PL (3); NZ (1); LA (1); DE (1); CL (1); IT (1)