Peripheral Arterial Disease
Conditions
Brief summary
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
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.
Interventions
DEVICEPQ Bypass Guide Wire Delivery System
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.
Sponsors
Endologix
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Patency | 30 days |
Countries
New Zealand
Outcome results
None listed