GORE-TEX PROPATEN Vascular Graft Study
Comparison of Primary Patency Between GORE-TEX PROPATEN Vascular Grafts and Thin Walled GORE-TEX Stretch Vascular Grafts
1 other identifier
interventional
200
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2003
Longer than P75 for not_applicable
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedAugust 7, 2008
August 1, 2008
September 12, 2005
August 6, 2008
Conditions
Outcome Measures
Primary Outcomes (2)
Primary patency at 12 months
Major device complication rates at 12 months
Secondary Outcomes (2)
Technical failures
Secondary patency
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Memorial Regional Hospital
Hollywood, Florida, 33028, United States
St. Vincent's Hospital
Jacksonville, Florida, 32204, United States
Sacred Heart Hospital
Pensacola, Florida, 32504, United States
Medical Center of Central Georgia
Macon, Georgia, 31201, United States
Jewish Hospital
Louisville, Kentucky, 40202, United States
Upper Chesapeake Medical Center
Baltimore, Maryland, 21014, United States
Baystate Medical Center
Springfield, Massachusetts, 01107, United States
Mercy Medical Center
Springfield, Massachusetts, 01107, United States
William Beaumont Hospital
Bingham Farms, Michigan, 48025, United States
Borgess Hospital
Kalamazoo, Michigan, 49048, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Morristown Memorial Hospital
Morristown, New Jersey, 07960, United States
Maimonides Hospital
Brooklyn, New York, 11219, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Wilkes-Barre General Hospital
Plains, Pennsylvania, 18705, United States
Baptist East Hospital
Memphis, Tennessee, 38120, United States
Charleston Area Medical Center
Charleston, West Virginia, 25304, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Enrico Ascher, MD
Maimonides Hospital, Brooklyn NY
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 20, 2005
Study Start
February 1, 2003
Study Completion
August 1, 2007
Last Updated
August 7, 2008
Record last verified: 2008-08