DETOUR I Clinical Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: PQ Bypass System for Femoropopliteal Bypass


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |