GORE-TEX PROPATEN Vascular Graft Study

This study has been completed.
Sponsor:
Information provided by:
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT00205790
First received: September 12, 2005
Last updated: August 6, 2008
Last verified: August 2008
  Purpose

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.


Condition Intervention
Peripheral Vascular Diseases
Device: Vascular graft

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Comparison of Primary Patency Between GORE-TEX PROPATEN Vascular Grafts and Thin Walled GORE-TEX Stretch Vascular Grafts

Resource links provided by NLM:


Further study details as provided by W.L.Gore & Associates:

Primary Outcome Measures:
  • Primary patency at 12 months
  • Major device complication rates at 12 months

Secondary Outcome Measures:
  • Technical failures
  • Secondary patency

Estimated Enrollment: 200
Study Start Date: February 2003
Study Completion Date: August 2007
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00205790

Locations
United States, District of Columbia
Georgetown University Hospital
Washington, District of Columbia, United States, 20007
United States, Florida
Memorial Regional Hospital
Hollywood, Florida, United States, 33028
St. Vincent's Hospital
Jacksonville, Florida, United States, 32204
Sacred Heart Hospital
Pensacola, Florida, United States, 32504
United States, Georgia
Medical Center of Central Georgia
Macon, Georgia, United States, 31201
United States, Kentucky
Jewish Hospital
Louisville, Kentucky, United States, 40202
United States, Maryland
Upper Chesapeake Medical Center
Baltimore, Maryland, United States, 21014
United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States, 01107
Mercy Medical Center
Springfield, Massachusetts, United States, 01107
United States, Michigan
William Beaumont Hospital
Bingham Farms, Michigan, United States, 48025
Borgess Hospital
Kalamazoo, Michigan, United States, 49048
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, New Jersey
Morristown Memorial Hospital
Morristown, New Jersey, United States, 07960
United States, New York
Maimonides Hospital
Brooklyn, New York, United States, 11219
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Wilkes-Barre General Hospital
Plains, Pennsylvania, United States, 18705
United States, Tennessee
Baptist East Hospital
Memphis, Tennessee, United States, 38120
United States, West Virginia
Charleston Area Medical Center
Charleston, West Virginia, United States, 25304
Sponsors and Collaborators
W.L.Gore & Associates
Investigators
Principal Investigator: Enrico Ascher, MD Maimonides Hospital, Brooklyn NY
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00205790     History of Changes
Other Study ID Numbers: PPT-01-04
Study First Received: September 12, 2005
Last Updated: August 6, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on April 17, 2014