GORE-TEX PROPATEN Vascular Graft Study

Peripheral Vascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00205790
• Other study ID #: PPT-01-04
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: August 6, 2008
• Start date: February 2003
• Est. completion date: August 2007

Study information

• Verified date: August 2008
• Source: W.L.Gore & Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Device:
• Vascular graft

Locations

Country	Name	City	State
United States	Upper Chesapeake Medical Center	Baltimore	Maryland
United States	William Beaumont Hospital	Bingham Farms	Michigan
United States	Maimonides Hospital	Brooklyn	New York
United States	Charleston Area Medical Center	Charleston	West Virginia
United States	Ohio State University Medical Center	Columbus	Ohio
United States	Memorial Regional Hospital	Hollywood	Florida
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	St. Vincent's Hospital	Jacksonville	Florida
United States	Borgess Hospital	Kalamazoo	Michigan
United States	Jewish Hospital	Louisville	Kentucky
United States	Medical Center of Central Georgia	Macon	Georgia
United States	Baptist East Hospital	Memphis	Tennessee
United States	Morristown Memorial Hospital	Morristown	New Jersey
United States	Sacred Heart Hospital	Pensacola	Florida
United States	Wilkes-Barre General Hospital	Plains	Pennsylvania
United States	Baystate Medical Center	Springfield	Massachusetts
United States	Mercy Medical Center	Springfield	Massachusetts
United States	Georgetown University Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary patency at 12 months
Primary	Major device complication rates at 12 months
Secondary	Technical failures
Secondary	Secondary patency