PQ Bypass Guide Wire Delivery System for Femoropopliteal Bypass (PQB4FP1)
Status
Conditions
Treatments
Details and patient eligibility
About
To assess the safety of performing a percutaneous fem-pop bypass using the PQ Bypass Guidewire Delivery System and commercially available stent grafts.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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Willing and able to provide informed consent
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Age 18 or older
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Rutherford Classification of 3-5
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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)
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Proximal and distal target vessels are 4.8 - 7.5 mm in diameter
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Orifice and proximal 1cm of SFA is patent
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Patent popliteal artery 3cm proximal to tibial plateau
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At least 1 patent tibial artery to the foot
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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
Trial design
Primary purpose
Allocation
Interventional model
Masking
4 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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