GORE-TEX PROPATEN Vascular Graft Study

Completed · Not applicable

Conditions studied: Peripheral Vascular Diseases

In brief

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.

Key facts

Study ID

NCT00205790

Run by

W.L.Gore & Associates

People needed

200

Starts

2003-02-01

Expected to finish

2007-08-01

Last updated by the study team

2008-08-07

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Georgetown University Hospital — Washington D.C., 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
• Borgess Hospital — Kalamazoo, Michigan, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Morristown Memorial Hospital — Morristown, New Jersey, United States
• Maimonides Hospital — Brooklyn, New York, United States
• Ohio State University Medical Center — Columbus, Ohio, United States
• Wilkes-Barre General Hospital — Plains, Pennsylvania, United States
• Baptist East Hospital — Memphis, Tennessee, United States
• Charleston Area Medical Center — Charleston, West Virginia, United States

Full record on ClinicalTrials.gov

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