Prevention of Autogenous Vein Graft Failure in Peripheral Artery Bypass Procedures
- Conditions
- HyperplasiaArterial Occlusive DiseasesPeripheral Vascular DiseasesIschemiaGraft Occlusion, Vascular
- Registration Number
- NCT00041925
- Lead Sponsor
- Anesiva, Inc.
- 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).
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1400
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (117)
Robert Packer Hospital
🇺🇸Sayre, Pennsylvania, United States
Vascular Specialists of Mobile, PC
🇺🇸Mobile, Alabama, United States
Springhill Memorial Hopsital
🇺🇸Mobile, Alabama, United States
Southern Arizona Vascular Institute
🇺🇸Tucson, Arizona, United States
Mobile Infirmary Medical Center
🇺🇸Mobile, Alabama, United States
Sarasota Memorial Hospital
🇺🇸Sarasota, Florida, United States
Saint Joseph's Hospital of Atlanta
🇺🇸Atlanta, Georgia, United States
Tucson Heart Hospital
🇺🇸Tucson, Arizona, United States
Baptist Health
🇺🇸Little Rock, Arkansas, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Emory University School of Medicine Hospital
🇺🇸Atlanta, Georgia, United States
VA Palo Alto Health Care System
🇺🇸Palo Alto, California, United States
Tucson Vascular Surgery
🇺🇸Tucson, Arizona, United States
University Medical Center
🇺🇸Lubbock, Texas, United States
Samson Showalter Vascular Specialists
🇺🇸Sarasota, Florida, United States
Clinical Research Center
🇺🇸Sarasota, Florida, United States
Vascular Institute of Georgia
🇺🇸Atlanta, Georgia, United States
Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
Maimonides Medical Center
🇺🇸Brooklyn, New York, United States
London Health Sciences Centre
🇨🇦London, Ontario, Canada
St. Paul's Hospital
🇨🇦Saskatoon, Saskatchewan, Canada
Vascular and Transplant Specialists, Peripheral Vascular Laboratory
🇺🇸Norfolk, Virginia, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
Peter Lougheed Centre
🇨🇦Calgary, Alberta, Canada
University of Chicago
🇺🇸Chicago, Illinois, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
New England Medical Center Hospital
🇺🇸Boston, Massachusetts, United States
Beth-Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
VA Puget Sound Health Care System
🇺🇸Seattle, Washington, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Veteran's Affairs Medical Center
🇺🇸Indianapolis, Indiana, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
VAMC
🇺🇸Houston, Texas, United States
Kaiser Permanente - San Diego, SCPMG, Department of Surgery
🇺🇸San Diego, California, United States
St. Thomas Medical
🇺🇸Nashville, Tennessee, United States
The Surgical Group, PLLC
🇺🇸Nashville, Tennessee, United States
Baptist Medical Center
🇺🇸San Antonio, Texas, United States
University of Utah Hospital and Clinics
🇺🇸Salt Lake City, Utah, 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
Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
The Kirklin Clinic
🇺🇸Birmingham, Alabama, United States
University Hospital
🇺🇸Birmingham, Alabama, United States
Kaiser Permanente Franklin Medical Center
🇺🇸Denver, Colorado, United States
Exempla Healthcare Saint Joseph Hospital
🇺🇸Denver, Colorado, United States
University Health Network
🇨🇦Toronto, Ontario, Canada
St. Boniface General Hospital
🇨🇦Winnipeg, Manitoba, Canada
Methodist Hospital
🇺🇸Omaha, Nebraska, United States
Froedert Memorial Lutheran Hospital
🇺🇸Milwaukee, Wisconsin, United States
St. Mary's Hospital
🇺🇸Rochester, Minnesota, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Clement J. Zablocki VAMC
🇺🇸Milwaukee, Wisconsin, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Northwest Hospital
🇺🇸Tucson, Arizona, United States
University of Arkansas for Medical Sciences Hospital
🇺🇸Little Rock, Arkansas, United States
Washington Hospital Center, Center for Vascular Care
🇺🇸Washington, District of Columbia, United States
Atlanta VA Medical Center
🇺🇸Decatur, Georgia, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
Our Lady of the Lake Regional Medical Center
🇺🇸Baton Rouge, Louisiana, United States
University of Maryland Hospital
🇺🇸Baltimore, Maryland, United States
Lakeland Hospital
🇺🇸St. Joseph, Michigan, United States
Dept. of Surgery at Harvard Medical Faculty Physicians
🇺🇸Boston, Massachusetts, United States
Brigham & Women's Hospital
🇺🇸Boston, Massachusetts, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Steven D. Rimar, M.D.
🇺🇸Troy, Michigan, United States
O.W. Brown, M.D.
🇺🇸Southfield, Michigan, United States
Washington University School of Medicine
🇺🇸St. Louis, Missouri, United States
Dr. Randy Shafrtiz, Clinical Office
🇺🇸Holmdel, New Jersey, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Morristown Memorial Hospital
🇺🇸Morristown, New Jersey, United States
Surgical Specialists of NJ, Morris Vascular Center
🇺🇸Morristown, New Jersey, United States
Robert Wood Johnson University Hospital
🇺🇸New Brunswick, New Jersey, United States
UMDNJ - New Jersey Medical School, University Hospital
🇺🇸Newark, New Jersey, United States
Albany Medical Center
🇺🇸Albany, New York, United States
New York Presbyterian Hospital, Weill Medical College of Cornell University
🇺🇸New York, New York, United States
SUNY Downstate University Hospital of Brooklyn and Medical School
🇺🇸Brooklyn, New York, United States
Kings County Hospital
🇺🇸Brooklyn, New York, United States
Columbia Presbyterian Medical Center
🇺🇸New York, New York, United States
Flower Hospital
🇺🇸Sylvania, Ohio, United States
Wake Forest University School of Medicine
🇺🇸Winston Salem, North Carolina, United States
Gaston Memorial Hospital
🇺🇸Gastonia, North Carolina, United States
Pitt County Memorial Hospital
🇺🇸Greenville, North Carolina, United States
Jobst Vascular Center
🇺🇸Toledo, Ohio, United States
Penn State College of Medicine
🇺🇸Hershey, Pennsylvania, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Veterans Administration Healthcare System
🇺🇸Pittsburgh, Pennsylvania, United States
University of Tennessee Medical Center
🇺🇸Knoxville, Tennessee, United States
Northeast Baptist Hospital
🇺🇸San Antonio, Texas, United States
Texas Tech University Health Sciences Center
🇺🇸Lubbock, Texas, United States
Virginia Vascular Associates
🇺🇸Norfolk, Virginia, United States
Shore Memorial Hospital
🇺🇸Nassawadox, Virginia, United States
Chesapeake General Hospital
🇺🇸Norfolk, Virginia, United States
Vascular and Transplant Specialsts, Peripheral and Vascular Laboratory
🇺🇸Chesapeake, Virginia, United States
Southampton Memorial Hospital
🇺🇸Franklin, Virginia, 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
Department of Surgery, Division of Vascular Surgery, East Carolina University
🇺🇸Greenville, North Carolina, United States
Umdnj-Rwjms
🇺🇸New Brunswick, New Jersey, United States
Vascular & Surgery Assoc.
🇺🇸Sarasota, Florida, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
The Toledo Hospital
🇺🇸Toledo, Ohio, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Central Arkansas Veterans Healthcare System
🇺🇸Little Rock, Arkansas, United States
Malcom Randall VA Medical Center
🇺🇸Gainesville, Florida, United States
Montefiore Hospital
🇺🇸Bronx, New York, United States
Medical University of South Carolina Hospital
🇺🇸Charleston, South Carolina, United States
Shands Hospital at the University of Florida
🇺🇸Gainesville, Florida, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Vancouver Hospital & Health Sciences Centre
🇨🇦Vancouver, British Columbia, Canada
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States