Prevention of Autogenous Vein Graft Failure in Peripheral Artery Bypass Procedures

NCT00041925 | Completed Phase 2

• 1 other identifier: CGT003-03
• Study Type: interventional
• Target: 1,400
• Locations: 2 countries
• Sites: 123

Brief 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).

Conditions

Peripheral Vascular Diseases; Arterial Occlusive Diseases; Ischemia; Graft Occlusion, Vascular; Hyperplasia

Keywords

atherosclerotic vascular disease; chronic critical limb ischemia; neointimal hyperplasia; peripheral vein bypass; infra-inguinal bypass grafting surgery; graft stenosis; occluded grafts

Interventions

CGT003 (E2F Duplex Decoy) DRUG

Eligibility Criteria

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

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Anesiva, Inc.: lead

Study Sites (123)

The Kirklin Clinic

Birmingham, Alabama, 35233, United States

Location

University Hospital

Birmingham, Alabama, 35294, United States

Location

Mobile Infirmary Medical Center

Mobile, Alabama, 36607, United States

Location

Vascular Specialists of Mobile, PC

Mobile, Alabama, 36607, United States

Location

Springhill Memorial Hopsital

Mobile, Alabama, 36608, United States

Location

Tucson Heart Hospital

Tucson, Arizona, 85704, United States

Location

University Medical Center

Tucson, Arizona, 85724, United States

Location

Northwest Hospital

Tucson, Arizona, 85741, United States

Location

Tucson Vascular Surgery

Tucson, Arizona, 85741, United States

Location

Southern Arizona Vascular Institute

Tucson, Arizona, 85745, United States

Location

St. Mary's Hospital

Tucson, Arizona, 85745, United States

Location

Baptist Health

Little Rock, Arkansas, 72205, United States

Location

Central Arkansas Veterans Healthcare System

Little Rock, Arkansas, 72205, United States

Location

University of Arkansas for Medical Sciences Hospital

Little Rock, Arkansas, 72205, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location

Kaiser Permanente - San Diego, SCPMG, Department of Surgery

San Diego, California, 92120, United States

Location

Kaiser Permanente Franklin Medical Center

Denver, Colorado, 80205, United States

Location

Exempla Healthcare Saint Joseph Hospital

Denver, Colorado, 80218, United States

Location

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Washington Hospital Center, Center for Vascular Care

Washington D.C., District of Columbia, 20010, United States

Location

Malcom Randall VA Medical Center

Gainesville, Florida, 32608, United States

Location

Shands Hospital at the University of Florida

Gainesville, Florida, 32610, United States

Location

Samson Showalter Vascular Specialists

Sarasota, Florida, 34233, United States

Location

Clinical Research Center

Sarasota, Florida, 34239, United States

Location

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

Location

Vascular & Surgery Assoc.

Sarasota, Florida, 34239, United States

Location

Tampa General Hospital

Tampa, Florida, 33601, United States

Location

Emory University School of Medicine Hospital

Atlanta, Georgia, 30322, United States

Location

Saint Joseph's Hospital of Atlanta

Atlanta, Georgia, 30342, United States

Location

Vascular Institute of Georgia

Atlanta, Georgia, 30342, United States

Location

Atlanta VA Medical Center

Decatur, Georgia, 30033, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Veteran's Affairs Medical Center

Indianapolis, Indiana, 46202, United States

Location

Our Lady of the Lake Regional Medical Center

Baton Rouge, Louisiana, 70808, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

University of Maryland Hospital

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

New England Medical Center Hospital

Boston, Massachusetts, 02111, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Beth-Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Dept. of Surgery at Harvard Medical Faculty Physicians

Boston, Massachusetts, 02215, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Lakeland Hospital

Saint Joseph, Michigan, 49085, United States

Location

O.W. Brown, M.D.

Southfield, Michigan, 48075, United States

Location

Steven D. Rimar, M.D.

Troy, Michigan, 48098, United States

Location

St. Mary's Hospital

Rochester, Minnesota, 55902, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Dr. Randy Shafrtiz, Clinical Office

Holmdel, New Jersey, 07733, United States

Location

Morristown Memorial Hospital

Morristown, New Jersey, 07960, United States

Location

Surgical Specialists of NJ, Morris Vascular Center

Morristown, New Jersey, 07960, United States

Location

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08903, United States

Location

Umdnj-Rwjms

New Brunswick, New Jersey, 08903, United States

Location

UMDNJ - New Jersey Medical School, University Hospital

Newark, New Jersey, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

Kings County Hospital

Brooklyn, New York, 11203, United States

Location

SUNY Downstate University Hospital of Brooklyn and Medical School

Brooklyn, New York, 11203, United States

Location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

New York Presbyterian Hospital, Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Columbia Presbyterian Medical Center

New York, New York, 10032, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Montefiore Hospital

The Bronx, New York, 10467, United States

Location

Gaston Memorial Hospital

Gastonia, North Carolina, 28054, United States

Location

Pitt County Memorial Hospital

Greenville, North Carolina, 27834, United States

Location

Department of Surgery, Division of Vascular Surgery, East Carolina University

Greenville, North Carolina, 27858, United States

Location

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Flower Hospital

Sylvania, Ohio, 43560, United States

Location

Jobst Vascular Center

Toledo, Ohio, 43606, United States

Location

The Toledo Hospital

Toledo, Ohio, 43606, United States

Location

Oregon Health Sciences University

Portland, Oregon, 97201, United States

Location

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Veterans Administration Healthcare System

Pittsburgh, Pennsylvania, 15240, United States

Location

Robert Packer Hospital

Sayre, Pennsylvania, 18840, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02905, United States

Location

Medical University of South Carolina Hospital

Charleston, South Carolina, 29425, United States

Location

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Location

St. Thomas Medical

Nashville, Tennessee, 37205, United States

Location

The Surgical Group, PLLC

Nashville, Tennessee, 37205, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

VAMC

Houston, Texas, 77030, United States

Location

University Medical Center

Lubbock, Texas, 79415, United States

Location

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

Baptist Medical Center

San Antonio, Texas, 78205, United States

Location

Peripheral Vascular Associates

San Antonio, Texas, 78215, United States

Location

Northeast Baptist Hospital

San Antonio, Texas, 78217, United States

Location

Peripheral Vascular Associates

San Antonio, Texas, 78217, United States

Location

Pro-Research Group

San Antonio, Texas, 78224, United States

Location

Southwest Texas Methodist Hospital

San Antonio, Texas, 78229, United States

Location

University of Utah Hospital and Clinics

Salt Lake City, Utah, 84132, United States

Location

Vascular and Transplant Specialists, Peripheral Vascular Laboratory

Chesapeake, Virginia, 23320, United States

Location

Vascular and Transplant Specialsts, Peripheral and Vascular Laboratory

Chesapeake, Virginia, 23320, United States

Location

Southampton Memorial Hospital

Franklin, Virginia, 23851, United States

Location

Shore Memorial Hospital

Nassawadox, Virginia, 23413, United States

Location

Chesapeake General Hospital

Norfolk, Virginia, 23502, United States

Location

Vascular and Transplant Specialists, Peripheral Vascular Laboratory

Norfolk, Virginia, 23502, United States

Location

Virginia Vascular Associates

Norfolk, Virginia, 23502, United States

Location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

Location

Vascular and Transplant Specialists, Peripheral Vascular Laboratory

Norfolk, Virginia, 23510, United States

Location

Carilion Roanoke Community Hospital

Roanoke, Virginia, 24014, United States

Location

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, 24014, United States

Location

Jefferson Surgical Clinic

Roanoke, Virginia, 24016, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

Froedert Memorial Lutheran Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Clement J. Zablocki VAMC

Milwaukee, Wisconsin, 53295, United States

Location

Peter Lougheed Centre

Calgary, Alberta, T1Y6J4, Canada

Location

Vancouver Hospital & Health Sciences Centre

Vancouver, British Columbia, V5Z 1M9, Canada

Location

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 4G5, Canada

Location

Ottawa Hospital

Ottawa, Ontario, KIY 4E9, Canada

Location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

St. Paul's Hospital

Saskatoon, Saskatchewan, S7M 0Z9, Canada

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases; Arterial Occlusive Diseases; Ischemia; Graft Occlusion, Vascular; Hyperplasia; Atherosclerosis

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Arteriosclerosis

Study Officials

• Todd Lorenz, M.D.

  Anesiva, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 18, 2002
• First Posted: July 22, 2002
• Study Start: November 1, 2001
• Study Completion: November 1, 2004
• Last Updated: July 15, 2005

Record last verified: 2005-07

Locations

US (116); CA (7)