DETOUR I Clinical Study for Percutaneous Femoropopliteal Bypass

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.

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.

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