GORE PROPATEN Vascular Graft vs. Disadvantaged Autologous Vein Graft

Stopped early · Phase 4

Conditions studied: Peripheral Arterial Occlusive Disease

In brief

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.

Key facts

Study ID

NCT00617279

Run by

W.L.Gore & Associates

People needed

31

Starts

2007-12-01

Expected to finish

2010-02-01

Last updated by the study team

2012-01-12

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University Of Alabama Medical Center — Birmingham, Alabama, United States
• Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Medical Center of Central Georgia — Macon, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• Vascular Specialty Associates — Baton Rouge, Louisiana, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Albany Medical Center — Albany, New York, United States
• Stonybrook University Medical Center — Stony Brook, New York, United States
• Montifiore Medical Center — The Bronx, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Greenville Hospital System — Greenville, South Carolina, United States
• University of Tennessee medical Center — Knoxville, Tennessee, United States
• The Methodist Hospital System — Houston, Texas, United States
• Peripheral Vascular Associates — San Antonio, Texas, United States
• Sentara Norfolk Hospital — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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