GORE PROPATEN Vascular Graft vs. Disadvantaged Autologous Vein Graft

NCT00617279 | Terminated Phase 4 Results

• 1 other identifier: PPT 07-05
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 17

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.

Conditions

Peripheral Arterial Occlusive Disease

Outcome Measures

Primary Outcomes (2)

• Number of Patients With Primary Patency at 12 Months Post-procedure

  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.

  12 months

• Major Adverse Event Occurrences Through One Month Post-procedure

  The number of Major Adverse Event occurrences through one month post-procedure. A major adverse event requires significant therapy, including unplanned increase in the level of care, permanent sequelae, hospitalization, or death. This outcome measure presents the number of Major Adverse Event occurrences (i.e. - one patient could have multiple occurrences), and differs from the Serious Adverse Events reporting measure, which presents the number of patients that have been affected by a Serious Adverse Event.

  one month post-index procedure

Secondary Outcomes (23)

• Number of Patients With Primary Patency at One Month Post-procedure

  One month

• Number of Patients With Primary Patency at 6 Months Post-procedure

  6 months

• Number of Patients With Assisted Primary Patency at One Month Post-procedure

  One month

• Number of Patients With Assisted Primary Patency at 6 Months Post-procedure

  6 months

• Number of Patients With Assisted Primary Patency at 12 Months Post-procedure

  12 months

Study Arms (2)

GORE PROPATEN Vascular Graft:

ACTIVE COMPARATOR

Device: GORE PROPATEN Vascular Graft

Disadvantaged Autologous Vein Graft

ACTIVE COMPARATOR

Procedure: Disadvantaged Autologous Vein Graft

Interventions

GORE PROPATEN Vascular Graft DEVICE

Arterial Occlusion Bypass

GORE PROPATEN Vascular Graft:

Disadvantaged Autologous Vein Graft PROCEDURE

Arterial Occlusion Bypass

Disadvantaged Autologous Vein Graft

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient requires below-knee bypass secondary to severe claudication, rest pain or tissue loss due to peripheral arterial occlusive disease.
• Patient meets the disadvantaged autologous vein criteria described in Section 4.1.
• Patient has a post-operative 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, 6, 12, 24 and 36-months post-procedure.
• Patient is willing and able to provide written, informed consent.

You may not qualify if:

• Patient has had a previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known hypersensitivity to heparin.
• Patient requires an infragenicular bypass for reasons other than peripheral arterial occlusive disease.
• Patient requires sequential extremity revascularizations or other procedures that require use of additional vascular grafts.
• 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.
• Patient has been previously randomized for this study.
• Patient has active infection in the region of graft placement.

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Study Sites (17)

University Of Alabama Medical Center

Birmingham, Alabama, 35294, United States

Location

Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30322, United States

Location

Medical Center of Central Georgia

Macon, Georgia, 31201, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Vascular Specialty Associates

Baton Rouge, Louisiana, 70809, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

Stonybrook University Medical Center

Stony Brook, New York, 11794, United States

Location

Montifiore Medical Center

The Bronx, New York, 10467, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Greenville Hospital System

Greenville, South Carolina, 29605, United States

Location

University of Tennessee medical Center

Knoxville, Tennessee, 37920, United States

Location

The Methodist Hospital System

Houston, Texas, 77030, United States

Location

Peripheral Vascular Associates

San Antonio, Texas, 78205, United States

Location

Sentara Norfolk Hospital

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Occlusive Disease 1

Limitations and Caveats

The study was terminated prior to completion of enrollment. The primary patency and secondary endpoints were not calculated due to the paucity of data.

Results Point of Contact

• Title: Chad Badorek, Clinical Study Manager
• Organization: W. L. Gore & Associates, Inc.

cbadorek@wlgore.com

928.864.3486

Study Officials

• Richard F. Neville, MD

  Georgetown University Hospital

  PRINCIPAL INVESTIGATOR

• Jennifer Recknor, Ph.D.

  W.L.Gore & Associates

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: February 18, 2008
• Study Start: December 1, 2007
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: January 12, 2012
• Results First Posted: January 12, 2012

Record last verified: 2011-12

Locations

US (17)