DETOUR I Clinical Study

PQ Bypass Systems for Femoropopliteal Bypass II (PQB 4 FP II)

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.

Study Overview

• Status: Unknown
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: PQ Bypass System for Femoropopliteal Bypass

Detailed Description

Prospective, single-arm, multi-center, international, non-randomized, pre-market, safety and effectiveness clinical investigation evaluating the PQ Bypass Systems to access, deliver guidewires and implant stent grafts for a percutaneous femoropopliteal (fem-pop) bypass.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Santiago, Chile
    • Universidad Catolica de Chile
• Germany
  • Leipzig, Germany, 04103
    • University of Leipzig Medical Centre
• Italy
  • Milan, Italy, 20132
    • Ospedale San Raffaele
• Latvia
  • Riga, Latvia, LV-1002
    • Stradins University Hospital
• New Zealand
  • Auckland, New Zealand, 1023
    • Vascular Service
• Poland
  • Gdańsk, Poland
    • Gdansk Medical University
  • Poznan, Poland, 61-848
    • Poznan University of Medical Sciences
  • Warsaw, Poland
    • Institute of Haematology Medicine Indira Gandhi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single arm study; PQ Bypass System for Femoropopliteal Bypass to complete percutaneous fem-pop bypass	Device: PQ Bypass System for Femoropopliteal Bypass; To access, deliver guidewires and implant stent grafts for a percutaneous fem-pop bypass.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Performance Endpoint (Rate of 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

Collaborators and Investigators

• Sponsor: PQ Bypass, Inc.

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): September 1, 2018
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: June 11, 2015
• First Submitted That Met QC Criteria: June 12, 2015
• First Posted (Estimate): June 15, 2015

Study Record Updates

• Last Update Posted (Actual): June 26, 2019
• Last Update Submitted That Met QC Criteria: June 24, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: STP 115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes