PQ Bypass Guide Wire Delivery System for Femoropopliteal Bypass

Study Overview
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Brief Summary
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To assess the safety of performing a percutaneous fem-pop bypass using the PQ Bypass Guidewire Delivery System and commercially available stent grafts.

Detailed Description
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Multi-center, single-arm first-in-man study utilizing the PQ Bypass Guide Wire Delivery System to access, deliver guidewires and implant stent grafts for a percutaneous femoropopliteal (fem-pop) bypass.

Official Title
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PQ Bypass Guide Wire Delivery System for Femoropopliteal Bypass

Conditions
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Peripheral Arterial Disease

Intervention / Treatment
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* Device: PQ Bypass Guide Wire Delivery System


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 Lesions ≥10cm 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 4.8 - 7.5 mm in diameter Orifice and proximal 1cm of SFA is patent Patent popliteal artery 3cm proximal to tibial plateau At least 1 patent tibial artery to the foot Patent femoral vein Exclusion Criteria: History of deep vein thrombosis Has a known sensitivity or allergy to contrast materials that cannot be adequately pre-treated Has a known sensitivity or allergy to aspirin, heparin or anti-platelet medications Documented in-sensitivity to anti-platelet medication Has a known or previous coagulopathy Pregnant or lactating Untreated flow-limiting aortoiliac occlusive disease Has renal failure (GFR < 30mL/min) Major distal amputation (above the transmetatarsal) in the study or non-study limb Patient has had a procedure on the target limb within 30 days Previous bypass surgery on the target limb Bypass length required is greater than 35cm

Ages Eligible for Study
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Minimum Age: 18 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: PQ Bypass Guide Wire Delivery System<br>PQ Bypass Guide Wire Delivery System to complete percutaneous Fem-pop bypass | Device: PQ Bypass Guide Wire Delivery System<br>* The PQ Bypass Guide Wire Delivery System is used to bypass lesions in the peripheral vasculature percutaneously. A guidewire is placed from the artery proximal to the lesion to the artery distal to the lesion using the vein as a conduit with the Guidewire Delivery System. Once in place, commercially available stent grafts will be placed to complete the bypass.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Patency |  | 30 days |