GORE PROPATEN Vascular Graft vs. Disadvantaged Autologous Vein Graft

NCT ID: NCT00617279

Last Updated: 2012-01-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2010-02-28

Brief Summary

The primary patency of the GORE PROPATEN Vascular Graft is equivalent to or better than disadvantaged autologous vein graft in an infragenicular peripheral bypass application at 12 months.

Detailed Description

Primary patency is defined as hemodynamic evidence of blood flow through an open graft that has maintained uninterrupted patency and has not previously undergone a revision to restore blood flow. A disadvantaged autologous vein is defined as meeting at least one of the two following criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator; (2) Usable ipsilateral or contralateral autologous greater saphenous vein that meets any of the following criteria: (a) Diameter of less than or equal to 3.0 mm; (b) Inadequate length requiring splicing; (c) Poor quality vein that is either sclerotic or phlebitic.

Conditions

Peripheral Arterial Occlusive Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GORE PROPATEN Vascular Graft:

Group Type: ACTIVE_COMPARATOR

GORE PROPATEN Vascular Graft

Intervention Type: DEVICE

Arterial Occlusion Bypass

Disadvantaged Autologous Vein Graft

Group Type: ACTIVE_COMPARATOR

Disadvantaged Autologous Vein Graft

Intervention Type: PROCEDURE

Arterial Occlusion Bypass

Interventions

GORE PROPATEN Vascular Graft

Arterial Occlusion Bypass

Intervention Type: DEVICE

Disadvantaged Autologous Vein Graft

Arterial Occlusion Bypass

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Patient requires below-knee bypass secondary to severe claudication, rest pain or tissue loss due to peripheral arterial occlusive disease.

2. Patient meets the disadvantaged autologous vein criteria described in Section 4.1.

3. Patient has a post-operative life expectancy greater than one year.

4. Patient is at least 21 years of age.

5. Patient is able to comply with all study requirements and be available for follow-up visits at 1, 6, 12, 24 and 36-months post-procedure.

6. Patient is willing and able to provide written, informed consent.

Exclusion Criteria

1. Patient has had a previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known hypersensitivity to heparin.

2. Patient requires an infragenicular bypass for reasons other than peripheral arterial occlusive disease.

3. Patient requires sequential extremity revascularizations or other procedures that require use of additional vascular grafts.

4. Patient is in need of, or is scheduled for, a cardiac surgical procedure or a different vascular surgical procedure within 30 days of study procedure. However, inflow procedures that facilitate the bypass are permitted, as long as they are not performed at the same sitting as the bypass procedure.

5. Patient has been previously randomized for this study.

6. Patient has active infection in the region of graft placement.

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

Sponsors

W.L.Gore & Associates

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard F. Neville, MD

Role: PRINCIPAL_INVESTIGATOR

Georgetown University Hospital

Jennifer Recknor, Ph.D.

Role: STUDY_DIRECTOR

W.L.Gore & Associates

Locations

University Of Alabama Medical Center

Birmingham, Alabama, United States

Georgetown University Hospital

Washington D.C., District of Columbia, United States

Emory University School of Medicine

Atlanta, Georgia, United States

Medical Center of Central Georgia

Macon, Georgia, United States

University of Chicago

Chicago, Illinois, United States

Vascular Specialty Associates

Baton Rouge, Louisiana, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Albany Medical Center

Albany, New York, United States

Stonybrook University Medical Center

Stony Brook, New York, United States

Montifiore Medical Center

The Bronx, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

Greenville Hospital System

Greenville, South Carolina, United States

University of Tennessee medical Center

Knoxville, Tennessee, United States

The Methodist Hospital System

Houston, Texas, United States

Peripheral Vascular Associates

San Antonio, Texas, United States

Sentara Norfolk Hospital

Norfolk, Virginia, United States

Countries

United States

Other Identifiers

PPT 07-05

Identifier Type: -

Identifier Source: org_study_id