Status:
COMPLETED
GORE-TEX PROPATEN Vascular Graft Study
Lead Sponsor:
W.L.Gore & Associates
Conditions:
Peripheral Vascular Diseases
Eligibility:
All Genders
21+ years
Phase:
NA
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 substan...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
End Date :
August 1 2007
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00205790
Start Date
February 1 2003
End Date
August 1 2007
Last Update
August 7 2008
Active Locations (18)
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1
Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
2
Memorial Regional Hospital
Hollywood, Florida, United States, 33028
3
St. Vincent's Hospital
Jacksonville, Florida, United States, 32204
4
Sacred Heart Hospital
Pensacola, Florida, United States, 32504