GORE-TEX PROPATEN Vascular Graft Study

NCT ID: NCT00205790

Last Updated: 2008-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-02-28
• Study Completion Date: 2007-08-31

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.

Conditions

Peripheral Vascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

Vascular graft

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

W.L.Gore & Associates

INDUSTRY

Sponsor Role: lead

Principal Investigators

Enrico Ascher, MD

Role: PRINCIPAL_INVESTIGATOR

Maimonides Hospital, Brooklyn NY

Locations

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

Countries

United States

Other Identifiers

PPT-01-04

Identifier Type: -

Identifier Source: org_study_id