Prevention of Autogenous Vein Graft Failure in Peripheral Artery Bypass Procedures

Ischemia Clinical Trial

Official title:

A Phase III, Multi-Center Randomized, Double-Blind, Placebo-Controlled Trial of the Ex Vivo Treatment With CGT003 of Peripheral Vein Grafts in Patients Undergoing Peripheral Arterial Bypass Graft Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00041925
• Other study ID #: CGT003-03
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 18, 2002
• Last updated: July 14, 2005
• Start date: November 2001
• Est. completion date: November 2004

Study information

• Verified date: July 2005
• Source: Anesiva, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the efficacy of graft pretreatment with the E2F decoy, CGT003, as compared to placebo, on the occurrence of graft failure among patients who receive autogenous vein grafts to treat chronic critical limb ischemia; on the occurrence of clinically significant graft stenosis (more than or equal to 70%); and on the incidence of critical limb ischemia (e.g., gangrene, non-healing ischemic ulcers or ischemic rest pain).

Description:

Peripheral vascular disease manifested by narrowing of the peripheral arteries is one of the more common manifestations of atherosclerotic vascular disease. Complications such as claudication, rest pain, and impaired wound healing are frequent and may result in gangrene and amputation. Restoration of circulation to the lower extremities may be undertaken using a variety of techniques including angioplasty, stenting, and bypass grafting.

Approximately 99,000 infra-inguinal bypass procedures were performed in the U.S. in 1998. It is estimated that approximately 22% of all infra-inguinal bypass grafts will fail by 12 months. Graft failure rates have been estimated to increase to 40% at 12 months for patients receiving composite, cephalic or lesser saphenous (high-risk) vein grafts (Vascular Surgery Registry, Brigham and Women’s Hospital). These primary graft failures are typically due to stenoses that result from neointimal hyperplasia, a pathological adaptation process that occurs in veins exposed to the arterial circulation. The consequences of graft failure are as significant as those of primary atherosclerotic disease and include ischemia and poor wound healing that may result in amputation. Since the long-term patency of venous grafts can be improved with treatment prior to frank occlusion, considerable efforts have been focused on the methods for the detection of grafts at high-risk for failure. Duplex ultrasonography has been determined to be a sensitive screening test for the early detection of failing grafts. Peak systolic velocity (PSV), as measured by duplex ultrasound, has been shown to be a sensitive marker for low flow, and wave form analysis has permitted the identification of areas of stenosis in the vein under study. Management of patients who have undergone infra-inguinal bypass therefore includes routine surveillance with duplex ultrasound and the immediate correction of significant (more than or equal to 70%) graft stenoses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1400
• Est. completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

PATIENTS MUST:

• Be scheduled to undergo infra-inguinal bypass grafting surgery using excised autogenous vein for Chronic Critical Limb Ischemia (i.e., rest pain, non-healing ulceration or gangrene). For patients presenting with rest pain as the only manifestation of CCLI, must have the diagnosis confirmed by at least one of the following,: i.) an ankle pressure of < 50 mmHg (or ABI <0.4), ii.) a toe pressure < 30 mmHg, iii.) a reduced TCPO2 < 30 mmHg, or iv.) a severely ischemic or flat line transtarsal pulse volume recording (i.e., Category V).

• Be males or females of at least 18 years old.

• Have agreed to participate voluntarily and signed and dated an IRB-approved, Patient Informed Consent form.

• Have a documented negative serum pregnancy test for all women of childbearing potential.

• Be using an acceptable method of birth control if of reproductive potential.

• Note: Patients undergoing operations to replace previously occluded grafts that involve placement of an entirely new bypass graft ARE eligible for this study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Graft Occlusion, Vascular
• Hyperplasia
• Ischemia
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Drug:
• CGT003 (E2F Duplex Decoy)

Locations

Country	Name	City	State
Canada	Peter Lougheed Centre	Calgary	Alberta
Canada	London Health Sciences Centre	London	Ontario
Canada	Ottawa Hospital	Ottawa	Ontario
Canada	St. Paul's Hospital	Saskatoon	Saskatchewan
Canada	University Health Network	Toronto	Ontario
Canada	Vancouver Hospital & Health Sciences Centre	Vancouver	British Columbia
Canada	St. Boniface General Hospital	Winnipeg	Manitoba
United States	Albany Medical Center	Albany	New York
United States	Emory University School of Medicine Hospital	Atlanta	Georgia
United States	Saint Joseph's Hospital of Atlanta	Atlanta	Georgia
United States	Vascular Institute of Georgia	Atlanta	Georgia
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	University of Maryland Hospital	Baltimore	Maryland
United States	Our Lady of the Lake Regional Medical Center	Baton Rouge	Louisiana
United States	The Kirklin Clinic	Birmingham	Alabama
United States	University Hospital	Birmingham	Alabama
United States	Beth-Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Dept. of Surgery at Harvard Medical Faculty Physicians	Boston	Massachusetts
United States	New England Medical Center Hospital	Boston	Massachusetts
United States	Montefiore Hospital	Bronx	New York
United States	Kings County Hospital	Brooklyn	New York
United States	Maimonides Medical Center	Brooklyn	New York
United States	SUNY Downstate University Hospital of Brooklyn and Medical School	Brooklyn	New York
United States	Medical University of South Carolina Hospital	Charleston	South Carolina
United States	Vascular and Transplant Specialists, Peripheral Vascular Laboratory	Chesapeake	Virginia
United States	Vascular and Transplant Specialsts, Peripheral and Vascular Laboratory	Chesapeake	Virginia
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Atlanta VA Medical Center	Decatur	Georgia
United States	Exempla Healthcare Saint Joseph Hospital	Denver	Colorado
United States	Kaiser Permanente Franklin Medical Center	Denver	Colorado
United States	Southampton Memorial Hospital	Franklin	Virginia
United States	Malcom Randall VA Medical Center	Gainesville	Florida
United States	Shands Hospital at the University of Florida	Gainesville	Florida
United States	Gaston Memorial Hospital	Gastonia	North Carolina
United States	Department of Surgery, Division of Vascular Surgery, East Carolina University	Greenville	North Carolina
United States	Pitt County Memorial Hospital	Greenville	North Carolina
United States	Hartford Hospital	Hartford	Connecticut
United States	Penn State College of Medicine	Hershey	Pennsylvania
United States	Dr. Randy Shafrtiz, Clinical Office	Holmdel	New Jersey
United States	Baylor College of Medicine	Houston	Texas
United States	VAMC	Houston	Texas
United States	Methodist Hospital	Indianapolis	Indiana
United States	Veteran's Affairs Medical Center	Indianapolis	Indiana
United States	University of Tennessee Medical Center	Knoxville	Tennessee
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Baptist Health	Little Rock	Arkansas
United States	Central Arkansas Veterans Healthcare System	Little Rock	Arkansas
United States	University of Arkansas for Medical Sciences Hospital	Little Rock	Arkansas
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Texas Tech University Health Sciences Center	Lubbock	Texas
United States	University Medical Center	Lubbock	Texas
United States	Clement J. Zablocki VAMC	Milwaukee	Wisconsin
United States	Froedert Memorial Lutheran Hospital	Milwaukee	Wisconsin
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Mobile Infirmary Medical Center	Mobile	Alabama
United States	Springhill Memorial Hopsital	Mobile	Alabama
United States	Vascular Specialists of Mobile, PC	Mobile	Alabama
United States	Morristown Memorial Hospital	Morristown	New Jersey
United States	Surgical Specialists of NJ, Morris Vascular Center	Morristown	New Jersey
United States	St. Thomas Medical	Nashville	Tennessee
United States	The Surgical Group, PLLC	Nashville	Tennessee
United States	Shore Memorial Hospital	Nassawadox	Virginia
United States	Robert Wood Johnson University Hospital	New Brunswick	New Jersey
United States	Umdnj-Rwjms	New Brunswick	New Jersey
United States	Columbia Presbyterian Medical Center	New York	New York
United States	Mount Sinai Medical Center	New York	New York
United States	New York Presbyterian Hospital, Weill Medical College of Cornell University	New York	New York
United States	UMDNJ - New Jersey Medical School, University Hospital	Newark	New Jersey
United States	Chesapeake General Hospital	Norfolk	Virginia
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Vascular and Transplant Specialists, Peripheral Vascular Laboratory	Norfolk	Virginia
United States	Vascular and Transplant Specialists, Peripheral Vascular Laboratory	Norfolk	Virginia
United States	Virginia Vascular Associates	Norfolk	Virginia
United States	Methodist Hospital	Omaha	Nebraska
United States	VA Palo Alto Health Care System	Palo Alto	California
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Veterans Administration Healthcare System	Pittsburgh	Pennsylvania
United States	Maine Medical Center	Portland	Maine
United States	Oregon Health Sciences University	Portland	Oregon
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Carilion Roanoke Community Hospital	Roanoke	Virginia
United States	Carilion Roanoke Memorial Hospital	Roanoke	Virginia
United States	Jefferson Surgical Clinic	Roanoke	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	St. Mary's Hospital	Rochester	Minnesota
United States	University of Rochester Medical Center	Rochester	New York
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	University of Utah Hospital and Clinics	Salt Lake City	Utah
United States	Baptist Medical Center	San Antonio	Texas
United States	Northeast Baptist Hospital	San Antonio	Texas
United States	Peripheral Vascular Associates	San Antonio	Texas
United States	Peripheral Vascular Associates	San Antonio	Texas
United States	Pro-Research Group	San Antonio	Texas
United States	Southwest Texas Methodist Hospital	San Antonio	Texas
United States	Kaiser Permanente - San Diego, SCPMG, Department of Surgery	San Diego	California
United States	Clinical Research Center	Sarasota	Florida
United States	Samson Showalter Vascular Specialists	Sarasota	Florida
United States	Sarasota Memorial Hospital	Sarasota	Florida
United States	Vascular & Surgery Assoc.	Sarasota	Florida
United States	Robert Packer Hospital	Sayre	Pennsylvania
United States	Harborview Medical Center	Seattle	Washington
United States	University of Washington Medical Center	Seattle	Washington
United States	VA Puget Sound Health Care System	Seattle	Washington
United States	O.W. Brown, M.D.	Southfield	Michigan
United States	Lakeland Hospital	St. Joseph	Michigan
United States	Washington University School of Medicine	St. Louis	Missouri
United States	Flower Hospital	Sylvania	Ohio
United States	Tampa General Hospital	Tampa	Florida
United States	Jobst Vascular Center	Toledo	Ohio
United States	The Toledo Hospital	Toledo	Ohio
United States	Steven D. Rimar, M.D.	Troy	Michigan
United States	Northwest Hospital	Tucson	Arizona
United States	Southern Arizona Vascular Institute	Tucson	Arizona
United States	St. Mary's Hospital	Tucson	Arizona
United States	Tucson Heart Hospital	Tucson	Arizona
United States	Tucson Vascular Surgery	Tucson	Arizona
United States	University Medical Center	Tucson	Arizona
United States	Washington Hospital Center, Center for Vascular Care	Washington	District of Columbia
United States	Wake Forest University School of Medicine	Winston Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Anesiva, Inc.

Countries where clinical trial is conducted

United States,  Canada,