Status:
TERMINATED
GORE PROPATEN Vascular Graft vs. Disadvantaged Autologous Vein Graft
Lead Sponsor:
W.L.Gore & Associates
Conditions:
Peripheral Arterial Occlusive Disease
Eligibility:
All Genders
21+ years
Phase:
PHASE4
Brief Summary
The primary patency of the GORE PROPATEN Vascular Graft is equivalent to or better than disadvantaged autologous vein graft in an infragenicular peripheral bypass application at 12 months.
Detailed Description
Primary patency is defined as hemodynamic evidence of blood flow through an open graft that has maintained uninterrupted patency and has not previously undergone a revision to restore blood flow. A di...
Eligibility Criteria
Inclusion
- Patient requires below-knee bypass secondary to severe claudication, rest pain or tissue loss due to peripheral arterial occlusive disease.
- Patient meets the disadvantaged autologous vein criteria described in Section 4.1.
- Patient has a post-operative 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, 6, 12, 24 and 36-months post-procedure.
- Patient is willing and able to provide written, informed consent.
Exclusion
- Patient has had a previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known hypersensitivity to heparin.
- Patient requires an infragenicular bypass for reasons other than peripheral arterial occlusive disease.
- Patient requires sequential extremity revascularizations or other procedures that require use of additional vascular grafts.
- Patient is in need of, or is scheduled for, a cardiac surgical procedure or a different vascular surgical procedure within 30 days of study procedure. However, inflow procedures that facilitate the bypass are permitted, as long as they are not performed at the same sitting as the bypass procedure.
- Patient has been previously randomized for this study.
- Patient has active infection in the region of graft placement.
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00617279
Start Date
December 1 2007
End Date
February 1 2010
Last Update
January 12 2012
Active Locations (17)
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1
University Of Alabama Medical Center
Birmingham, Alabama, United States, 35294
2
Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
3
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
4
Medical Center of Central Georgia
Macon, Georgia, United States, 31201