GORE-TEX PROPATEN Vascular Graft Study
- Conditions
- Peripheral Vascular Diseases
- Registration Number
- NCT00205790
- Lead Sponsor
- W.L.Gore & Associates
- Brief Summary
To demonstrate equivalence in patency performance of GORE-TEX PROPATEN Vascular Grafts and Thin Walled GORE-TEX Stretch Vascular Grafts in a peripheral bypass application to support a claim of substantial equivalence.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- Patient requires primary above-knee bypass where the proximal anastomosis will be to the common femoral or proximal superficial femoral artery and the distal anastomosis will be the popliteal artery proximal to the medial head of the gastrocnemius;
- Patient has Grade III or IV occlusive vascular disease;
- Patient has a postoperative life expectancy greater than one year;
- Patient is at least 21 years of age;
- Patient is able to comply with all study requirements and be available for follow-up visits at 1 month, 6 months and 12 months post procedure;
- Patient is willing and able to provide written, informed consent.
- Patient had a previous bypass in the diseased extremity (below iliacs);
- Patient has known coagulation disorders including hypercoagulability;
- Patient has had any previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known hypersensitivity to heparin;
- Patient has an acute embolic arterial occlusion;
- Patient requires sequential extremity revascularizations or other procedures that require use of additional vascular grafts;
- Patient had percutaneous transluminal angioplasty to the implant site within the previous 30 days;
- Patient is in need of, or is scheduled for, a cardiac surgical procedure or a different vascular surgical procedure;
- Patient has active infection in the region of graft placement; or
- Patient has an incomplete preoperative assessment (as outlined in this protocol) due to an emergency procedure, a traumatic injury or any other reason.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Primary patency at 12 months Major device complication rates at 12 months
- Secondary Outcome Measures
Name Time Method Technical failures Secondary patency
Trial Locations
- Locations (18)
Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
Memorial Regional Hospital
🇺🇸Hollywood, Florida, United States
St. Vincent's Hospital
🇺🇸Jacksonville, Florida, United States
Sacred Heart Hospital
🇺🇸Pensacola, Florida, United States
Medical Center of Central Georgia
🇺🇸Macon, Georgia, United States
Jewish Hospital
🇺🇸Louisville, Kentucky, United States
Upper Chesapeake Medical Center
🇺🇸Baltimore, Maryland, United States
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
Mercy Medical Center
🇺🇸Springfield, Massachusetts, United States
William Beaumont Hospital
🇺🇸Bingham Farms, Michigan, United States
Scroll for more (8 remaining)Georgetown University Hospital🇺🇸Washington, District of Columbia, United States