GORE-TEX PROPATEN Vascular Graft Study

Comparison of Primary Patency Between GORE-TEX PROPATEN Vascular Grafts and Thin Walled GORE-TEX Stretch Vascular Grafts

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Vascular Diseases
• Intervention / Treatment: Device: Vascular graft

• Study Type: Interventional
• Enrollment: 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Primary patency at 12 months
Major device complication rates at 12 months

Secondary Outcome Measures

Outcome Measure
Technical failures
Secondary patency

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates
• Investigators: Principal Investigator: Enrico Ascher, MD, Maimonides Hospital, Brooklyn NY

Study record dates

Study Major Dates

• Study Start: February 1, 2003
• Study Completion (Actual): August 1, 2007

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 20, 2005

Study Record Updates

• Last Update Posted (Estimate): August 7, 2008
• Last Update Submitted That Met QC Criteria: August 6, 2008
• Last Verified: August 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: PPT-01-04