Clinical Trial: Prevention of Autogenous Vein Graft Failure in Peripheral Artery Bypass Procedures

This study is no longer recruiting patients.

Sponsored by: Corgentech
Information provided by: Corgentech

Purpose

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).

Condition Treatment or Intervention Phase
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Ischemia
Graft Occlusion, Vascular
Hyperplasia
 Drug: CGT003 (E2F Duplex Decoy)
Phase II
Phase III

MedlinePlus related topics:  Peripheral Vascular Diseases;   Vascular Diseases

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

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

Further Study Details: 

Expected Total Enrollment:  1400

Study start: November 2001

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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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.

Location Information


Alabama
      Mobile Infirmary Medical Center, Mobile,  Alabama,  36607,  United States

      Vascular Specialists of Mobile, PC, Mobile,  Alabama,  36607,  United States

      Springhill Memorial Hopsital, Mobile,  Alabama,  36608,  United States

      The Kirklin Clinic, Birmingham,  Alabama,  35233,  United States

      University Hospital, Birmingham,  Alabama,  35294,  United States

Arizona
      St. Mary's Hospital, Tucson,  Arizona,  85745,  United States

      University Medical Center, Tucson,  Arizona,  85724,  United States

      Northwest Hospital, Tucson,  Arizona,  85741,  United States

      Southern Arizona Vascular Institute, Tucson,  Arizona,  85745,  United States

      Tucson Heart Hospital, Tucson,  Arizona,  85704,  United States

      Tucson Vascular Surgery, Tucson,  Arizona,  85741,  United States

Arkansas
      University of Arkansas for Medical Sciences Hospital, Little Rock,  Arkansas,  72205,  United States

      Central Arkansas Veterans Healthcare System, Little Rock,  Arkansas,  72205,  United States

      Baptist Health, Little Rock,  Arkansas,  72205,  United States

California
      Cedars-Sinai Medical Center, Los Angeles,  California,  90048,  United States

      VA Palo Alto Health Care System, Palo Alto,  California,  94304,  United States

      Kaiser Permanente - San Diego, SCPMG, Department of Surgery, San Diego,  California,  92120,  United States

Colorado
      Kaiser Permanente Franklin Medical Center, Denver,  Colorado,  80205,  United States

      Exempla Healthcare Saint Joseph Hospital, Denver,  Colorado,  80218,  United States

Connecticut
      Hartford Hospital, Hartford,  Connecticut,  06102,  United States

District of Columbia
      Washington Hospital Center, Center for Vascular Care, Washington,  District of Columbia,  20010,  United States

Florida
      Tampa General Hospital, Tampa,  Florida,  33601,  United States

      Shands Hospital at the University of Florida, Gainesville,  Florida,  32610,  United States

      Samson Showalter Vascular Specialists, Sarasota,  Florida,  34233,  United States

      Malcom Randall VA Medical Center, Gainesville,  Florida,  32608,  United States

      Vascular & Surgery Assoc., Sarasota,  Florida,  34239,  United States

      Sarasota Memorial Hospital, Sarasota,  Florida,  34239,  United States

      Clinical Research Center, Sarasota,  Florida,  34239,  United States

Georgia
      Emory University School of Medicine Hospital, Atlanta,  Georgia,  30322,  United States

      Atlanta VA Medical Center, Decatur,  Georgia,  30033,  United States

      Saint Joseph's Hospital of Atlanta, Atlanta,  Georgia,  30342,  United States

      Vascular Institute of Georgia, Atlanta,  Georgia,  30342,  United States

Illinois
      Northwestern Memorial Hospital, Chicago,  Illinois,  60611,  United States

      University of Chicago, Chicago,  Illinois,  60637,  United States

Indiana
      Methodist Hospital, Indianapolis,  Indiana,  46202,  United States

      Veteran's Affairs Medical Center, Indianapolis,  Indiana,  46202,  United States

Louisiana
      Our Lady of the Lake Regional Medical Center, Baton Rouge,  Louisiana,  70808,  United States

Maine
      Maine Medical Center, Portland,  Maine,  04102,  United States

Maryland
      University of Maryland Hospital, Baltimore,  Maryland,  21201,  United States

      Johns Hopkins Hospital, Baltimore,  Maryland,  21287,  United States

Massachusetts
      Brigham & Women's Hospital, Boston,  Massachusetts,  02115,  United States

      Beth-Israel Deaconess Medical Center, Boston,  Massachusetts,  02215,  United States

      New England Medical Center Hospital, Boston,  Massachusetts,  02111,  United States

      Dept. of Surgery at Harvard Medical Faculty Physicians, Boston,  Massachusetts,  02215,  United States

Michigan
      William Beaumont Hospital, Royal Oak,  Michigan,  48073,  United States

      Lakeland Hospital, St. Joseph,  Michigan,  49085,  United States

      Steven D. Rimar, M.D., Troy,  Michigan,  48098,  United States

      O.W. Brown, M.D., Southfield,  Michigan,  48075,  United States

Minnesota
      Mayo Clinic, Rochester,  Minnesota,  55905,  United States

      St. Mary's Hospital, Rochester,  Minnesota,  55902,  United States

Missouri
      Washington University School of Medicine, St. Louis,  Missouri,  63110,  United States

Nebraska
      Methodist Hospital, Omaha,  Nebraska,  68114,  United States

New Hampshire
      Dartmouth Hitchcock Medical Center, Lebanon,  New Hampshire,  03756,  United States

New Jersey
      Morristown Memorial Hospital, Morristown,  New Jersey,  07960,  United States

      UMDNJ-RWJMS, New Brunswick,  New Jersey,  08903,  United States

      Robert Wood Johnson University Hospital, New Brunswick,  New Jersey,  08903,  United States

      UMDNJ - New Jersey Medical School, University Hospital, Newark,  New Jersey,  United States

      Surgical Specialists of NJ, Morris Vascular Center, Morristown,  New Jersey,  07960,  United States

      Dr. Randy Shafrtiz, Clinical Office, Holmdel,  New Jersey,  07733,  United States

New York
      University of Rochester Medical Center, Rochester,  New York,  14642,  United States

      Mount Sinai Medical Center, New York,  New York,  10029,  United States

      Albany Medical Center, Albany,  New York,  12208,  United States

      Montefiore Hospital, Bronx,  New York,  10467,  United States

      New York Presbyterian Hospital, Weill Medical College of Cornell University, New York,  New York,  10021,  United States

      Maimonides Medical Center, Brooklyn,  New York,  11219,  United States

      SUNY Downstate University Hospital of Brooklyn and Medical School, Brooklyn,  New York,  11203,  United States

      Kings County Hospital, Brooklyn,  New York,  11203,  United States

      Columbia Presbyterian Medical Center, New York,  New York,  10032,  United States

North Carolina
      Wake Forest University School of Medicine, Winston Salem,  North Carolina,  27157,  United States

      Gaston Memorial Hospital, Gastonia,  North Carolina,  28054,  United States

      Department of Surgery, Division of Vascular Surgery, East Carolina University, Greenville,  North Carolina,  27858,  United States

      Pitt County Memorial Hospital, Greenville,  North Carolina,  27834,  United States

Ohio
      Cleveland Clinic Foundation, Cleveland,  Ohio,  44195,  United States

      Jobst Vascular Center, Toledo,  Ohio,  43606,  United States

      The Toledo Hospital, Toledo,  Ohio,  43606,  United States

      Flower Hospital, Sylvania,  Ohio,  43560,  United States

Oregon
      Oregon Health Sciences University, Portland,  Oregon,  97201,  United States

Pennsylvania
      Robert Packer Hospital, Sayre,  Pennsylvania,  18840,  United States

      Temple University Hospital, Philadelphia,  Pennsylvania,  19140,  United States

      Hospital of the University of Pennsylvania, Philadelphia,  Pennsylvania,  19104,  United States

      Penn State College of Medicine, Hershey,  Pennsylvania,  17033,  United States

      Veterans Administration Healthcare System, Pittsburgh,  Pennsylvania,  15240,  United States

Rhode Island
      Rhode Island Hospital, Providence,  Rhode Island,  02905,  United States

South Carolina
      Medical University of South Carolina Hospital, Charleston,  South Carolina,  29425,  United States

Tennessee
      St. Thomas Medical, Nashville,  Tennessee,  37205,  United States

      The Surgical Group, PLLC, Nashville,  Tennessee,  37205,  United States

      University of Tennessee Medical Center, Knoxville,  Tennessee,  37920,  United States

Texas
      Baylor College of Medicine, Houston,  Texas,  77030,  United States

      Southwest Texas Methodist Hospital, San Antonio,  Texas,  78229,  United States

      Texas Tech University Health Sciences Center, Lubbock,  Texas,  79430,  United States

      University Medical Center, Lubbock,  Texas,  79415,  United States

      Peripheral Vascular Associates, San Antonio,  Texas,  78215,  United States

      Baptist Medical Center, San Antonio,  Texas,  78205,  United States

      Northeast Baptist Hospital, San Antonio,  Texas,  78217,  United States

      Pro-Research Group, San Antonio,  Texas,  78224,  United States

      Peripheral Vascular Associates, San Antonio,  Texas,  78217,  United States

      VAMC, Houston,  Texas,  77030,  United States

Utah
      University of Utah Hospital and Clinics, Salt Lake City,  Utah,  84132,  United States

Virginia
      Sentara Norfolk General Hospital, Norfolk,  Virginia,  23507,  United States

      Chesapeake General Hospital, Norfolk,  Virginia,  23502,  United States

      Virginia Vascular Associates, Norfolk,  Virginia,  23502,  United States

      Carilion Roanoke Community Hospital, Roanoke,  Virginia,  24014,  United States

      Carilion Roanoke Memorial Hospital, Roanoke,  Virginia,  24014,  United States

      Jefferson Surgical Clinic, Roanoke,  Virginia,  24016,  United States

      Vascular and Transplant Specialists, Peripheral Vascular Laboratory, Chesapeake,  Virginia,  23320,  United States

      Vascular and Transplant Specialists, Peripheral Vascular Laboratory, Norfolk,  Virginia,  23510,  United States

      Southampton Memorial Hospital, Franklin,  Virginia,  23851,  United States

      Shore Memorial Hospital, Nassawadox,  Virginia,  23413,  United States

      Vascular and Transplant Specialsts, Peripheral and Vascular Laboratory, Chesapeake,  Virginia,  23320,  United States

      Vascular and Transplant Specialists, Peripheral Vascular Laboratory, Norfolk,  Virginia,  23502,  United States

      Vascular and Transplant Specialists, Peripheral Vascular Laboratory, Norfolk,  Virginia,  23510,  United States

      Southampton Memorial Hospital, Franklin,  Virginia,  23851,  United States

      Shore Memorial Hospital, Nassawadox,  Virginia,  23413,  United States

Washington
      Harborview Medical Center, Seattle,  Washington,  98104,  United States

      VA Puget Sound Health Care System, Seattle,  Washington,  98108,  United States

      University of Washington Medical Center, Seattle,  Washington,  98195,  United States

Wisconsin
      Clement J. Zablocki VAMC, Milwaukee,  Wisconsin,  53295,  United States

      Medical College of Wisconsin, Milwaukee,  Wisconsin,  53226,  United States

      Froedert Memorial Lutheran Hospital, Milwaukee,  Wisconsin,  53226,  United States

Canada, Alberta
      Peter Lougheed Centre, Calgary,  Alberta,  T1Y6J4,  Canada

Canada, British Columbia
      Vancouver Hospital & Health Sciences Centre, Vancouver,  British Columbia,  V5Z 1M9,  Canada

Canada, Manitoba
      St. Boniface General Hospital, Winnipeg,  Manitoba,  R2H 2A6,  Canada

Canada, Ontario
      London Health Sciences Centre, London,  Ontario,  N6A 4G5,  Canada

      Ottawa Hospital, Ottawa,  Ontario,  KIY 4E9,  Canada

      University Health Network, Toronto,  Ontario,  M5G 2C4,  Canada

Canada, Saskatchewan
      St. Paul's Hospital, Saskatoon,  Saskatchewan,  S7M 0Z9,  Canada

Study chairs or principal investigators

Todd Lorenz, M.D.,  Study Director,  Corgentech   

More Information

Study ID Numbers:  CGT003-03
Record last reviewed:  March 2005
Last Updated:  March 22, 2005
Record first received:  July 18, 2002
ClinicalTrials.gov Identifier:  NCT00041925
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005