Prevention of Autogenous Vein Graft Failure in Peripheral Artery Bypass Procedures
This study has been completed.
Sponsor:
Anesiva, Inc.
Information provided by:
Anesiva, Inc.
ClinicalTrials.gov Identifier:
NCT00041925
First received: July 18, 2002
Last updated: July 14, 2005
Last verified: July 2005
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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 | Intervention | Phase |
|---|---|---|
|
Peripheral Vascular Diseases Arterial Occlusive Diseases Ischemia Graft Occlusion, Vascular Hyperplasia |
Drug: CGT003 (E2F Duplex Decoy) |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
Further study details as provided by Anesiva, Inc.:
| Estimated Enrollment: | 1400 |
| Study Start Date: | November 2001 |
| Estimated Study Completion Date: | November 2004 |
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 older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00041925
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| United States, Alabama | |
| University Hospital | |
| Birmingham, Alabama, United States, 35294 | |
| The Kirklin Clinic | |
| Birmingham, Alabama, United States, 35233 | |
| Vascular Specialists of Mobile, PC | |
| Mobile, Alabama, United States, 36607 | |
| Springhill Memorial Hopsital | |
| Mobile, Alabama, United States, 36608 | |
| Mobile Infirmary Medical Center | |
| Mobile, Alabama, United States, 36607 | |
| United States, Arizona | |
| St. Mary's Hospital | |
| Tucson, Arizona, United States, 85745 | |
| University Medical Center | |
| Tucson, Arizona, United States, 85724 | |
| Northwest Hospital | |
| Tucson, Arizona, United States, 85741 | |
| Southern Arizona Vascular Institute | |
| Tucson, Arizona, United States, 85745 | |
| Tucson Heart Hospital | |
| Tucson, Arizona, United States, 85704 | |
| Tucson Vascular Surgery | |
| Tucson, Arizona, United States, 85741 | |
| United States, Arkansas | |
| University of Arkansas for Medical Sciences Hospital | |
| Little Rock, Arkansas, United States, 72205 | |
| Central Arkansas Veterans Healthcare System | |
| Little Rock, Arkansas, United States, 72205 | |
| Baptist Health | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Cedars-Sinai Medical Center | |
| Los Angeles, California, United States, 90048 | |
| VA Palo Alto Health Care System | |
| Palo Alto, California, United States, 94304 | |
| Kaiser Permanente - San Diego, SCPMG, Department of Surgery | |
| San Diego, California, United States, 92120 | |
| United States, Colorado | |
| Kaiser Permanente Franklin Medical Center | |
| Denver, Colorado, United States, 80205 | |
| Exempla Healthcare Saint Joseph Hospital | |
| Denver, Colorado, United States, 80218 | |
| United States, Connecticut | |
| Hartford Hospital | |
| Hartford, Connecticut, United States, 06102 | |
| United States, District of Columbia | |
| Washington Hospital Center, Center for Vascular Care | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| Malcom Randall VA Medical Center | |
| Gainesville, Florida, United States, 32608 | |
| Shands Hospital at the University of Florida | |
| Gainesville, Florida, United States, 32610 | |
| Samson Showalter Vascular Specialists | |
| Sarasota, Florida, United States, 34233 | |
| Vascular & Surgery Assoc. | |
| Sarasota, Florida, United States, 34239 | |
| Sarasota Memorial Hospital | |
| Sarasota, Florida, United States, 34239 | |
| Clinical Research Center | |
| Sarasota, Florida, United States, 34239 | |
| Tampa General Hospital | |
| Tampa, Florida, United States, 33601 | |
| United States, Georgia | |
| Saint Joseph's Hospital of Atlanta | |
| Atlanta, Georgia, United States, 30342 | |
| Emory University School of Medicine Hospital | |
| Atlanta, Georgia, United States, 30322 | |
| Vascular Institute of Georgia | |
| Atlanta, Georgia, United States, 30342 | |
| Atlanta VA Medical Center | |
| Decatur, Georgia, United States, 30033 | |
| United States, Illinois | |
| Northwestern Memorial Hospital | |
| Chicago, Illinois, United States, 60611 | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| United States, Indiana | |
| Methodist Hospital | |
| Indianapolis, Indiana, United States, 46202 | |
| Veteran's Affairs Medical Center | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Louisiana | |
| Our Lady of the Lake Regional Medical Center | |
| Baton Rouge, Louisiana, United States, 70808 | |
| United States, Maine | |
| Maine Medical Center | |
| Portland, Maine, United States, 04102 | |
| United States, Maryland | |
| University of Maryland Hospital | |
| Baltimore, Maryland, United States, 21201 | |
| Johns Hopkins Hospital | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Massachusetts | |
| Brigham & Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| Beth-Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| New England Medical Center Hospital | |
| Boston, Massachusetts, United States, 02111 | |
| Dept. of Surgery at Harvard Medical Faculty Physicians | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Michigan | |
| William Beaumont Hospital | |
| Royal Oak, Michigan, United States, 48073 | |
| O.W. Brown, M.D. | |
| Southfield, Michigan, United States, 48075 | |
| Lakeland Hospital | |
| St. Joseph, Michigan, United States, 49085 | |
| Steven D. Rimar, M.D. | |
| Troy, Michigan, United States, 48098 | |
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| St. Mary's Hospital | |
| Rochester, Minnesota, United States, 55902 | |
| United States, Missouri | |
| Washington University School of Medicine | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
| Methodist Hospital | |
| Omaha, Nebraska, United States, 68114 | |
| United States, New Hampshire | |
| Dartmouth Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756 | |
| United States, New Jersey | |
| Dr. Randy Shafrtiz, Clinical Office | |
| Holmdel, New Jersey, United States, 07733 | |
| Morristown Memorial Hospital | |
| Morristown, New Jersey, United States, 07960 | |
| Surgical Specialists of NJ, Morris Vascular Center | |
| Morristown, New Jersey, United States, 07960 | |
| Robert Wood Johnson University Hospital | |
| New Brunswick, New Jersey, United States, 08903 | |
| Umdnj-Rwjms | |
| New Brunswick, New Jersey, United States, 08903 | |
| UMDNJ - New Jersey Medical School, University Hospital | |
| Newark, New Jersey, United States | |
| United States, New York | |
| Albany Medical Center | |
| Albany, New York, United States, 12208 | |
| Montefiore Hospital | |
| Bronx, New York, United States, 10467 | |
| Maimonides Medical Center | |
| Brooklyn, New York, United States, 11219 | |
| Kings County Hospital | |
| Brooklyn, New York, United States, 11203 | |
| SUNY Downstate University Hospital of Brooklyn and Medical School | |
| Brooklyn, New York, United States, 11203 | |
| New York Presbyterian Hospital, Weill Medical College of Cornell University | |
| New York, New York, United States, 10021 | |
| Columbia Presbyterian Medical Center | |
| New York, New York, United States, 10032 | |
| Mount Sinai Medical Center | |
| New York, New York, United States, 10029 | |
| University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| United States, North Carolina | |
| Gaston Memorial Hospital | |
| Gastonia, North Carolina, United States, 28054 | |
| Department of Surgery, Division of Vascular Surgery, East Carolina University | |
| Greenville, North Carolina, United States, 27858 | |
| Pitt County Memorial Hospital | |
| Greenville, North Carolina, United States, 27834 | |
| Wake Forest University School of Medicine | |
| Winston Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
| Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| Flower Hospital | |
| Sylvania, Ohio, United States, 43560 | |
| The Toledo Hospital | |
| Toledo, Ohio, United States, 43606 | |
| Jobst Vascular Center | |
| Toledo, Ohio, United States, 43606 | |
| United States, Oregon | |
| Oregon Health Sciences University | |
| Portland, Oregon, United States, 97201 | |
| United States, Pennsylvania | |
| Penn State College of Medicine | |
| Hershey, Pennsylvania, United States, 17033 | |
| Temple University Hospital | |
| Philadelphia, Pennsylvania, United States, 19140 | |
| Hospital of the University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Veterans Administration Healthcare System | |
| Pittsburgh, Pennsylvania, United States, 15240 | |
| Robert Packer Hospital | |
| Sayre, Pennsylvania, United States, 18840 | |
| United States, Rhode Island | |
| Rhode Island Hospital | |
| Providence, Rhode Island, United States, 02905 | |
| United States, South Carolina | |
| Medical University of South Carolina Hospital | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Tennessee | |
| University of Tennessee Medical Center | |
| Knoxville, Tennessee, United States, 37920 | |
| St. Thomas Medical | |
| Nashville, Tennessee, United States, 37205 | |
| The Surgical Group, PLLC | |
| Nashville, Tennessee, United States, 37205 | |
| United States, Texas | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| VAMC | |
| Houston, Texas, United States, 77030 | |
| Texas Tech University Health Sciences Center | |
| Lubbock, Texas, United States, 79430 | |
| University Medical Center | |
| Lubbock, Texas, United States, 79415 | |
| Peripheral Vascular Associates | |
| San Antonio, Texas, United States, 78217 | |
| Baptist Medical Center | |
| San Antonio, Texas, United States, 78205 | |
| Northeast Baptist Hospital | |
| San Antonio, Texas, United States, 78217 | |
| Pro-Research Group | |
| San Antonio, Texas, United States, 78224 | |
| Southwest Texas Methodist Hospital | |
| San Antonio, Texas, United States, 78229 | |
| Peripheral Vascular Associates | |
| San Antonio, Texas, United States, 78215 | |
| United States, Utah | |
| University of Utah Hospital and Clinics | |
| Salt Lake City, Utah, United States, 84132 | |
| United States, Virginia | |
| Vascular and Transplant Specialists, Peripheral Vascular Laboratory | |
| Chesapeake, Virginia, United States, 23320 | |
| Vascular and Transplant Specialsts, Peripheral and Vascular Laboratory | |
| Chesapeake, Virginia, United States, 23320 | |
| Southampton Memorial Hospital | |
| Franklin, Virginia, United States, 23851 | |
| Shore Memorial Hospital | |
| Nassawadox, Virginia, United States, 23413 | |
| Chesapeake General Hospital | |
| Norfolk, Virginia, United States, 23502 | |
| Sentara Norfolk General Hospital | |
| Norfolk, Virginia, United States, 23507 | |
| Virginia Vascular Associates | |
| Norfolk, Virginia, United States, 23502 | |
| Vascular and Transplant Specialists, Peripheral Vascular Laboratory | |
| Norfolk, Virginia, United States, 23502 | |
| Vascular and Transplant Specialists, Peripheral Vascular Laboratory | |
| Norfolk, Virginia, United States, 23510 | |
| Carilion Roanoke Community Hospital | |
| Roanoke, Virginia, United States, 24014 | |
| Carilion Roanoke Memorial Hospital | |
| Roanoke, Virginia, United States, 24014 | |
| Jefferson Surgical Clinic | |
| Roanoke, Virginia, United States, 24016 | |
| United States, Washington | |
| Harborview Medical Center | |
| Seattle, Washington, United States, 98104 | |
| VA Puget Sound Health Care System | |
| Seattle, Washington, United States, 98108 | |
| University of Washington Medical Center | |
| Seattle, Washington, United States, 98195 | |
| United States, Wisconsin | |
| Clement J. Zablocki VAMC | |
| Milwaukee, Wisconsin, United States, 53295 | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Froedert Memorial Lutheran Hospital | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Canada, Alberta | |
| Peter Lougheed Centre | |
| Calgary, Alberta, Canada, T1Y6J4 | |
| Canada, British Columbia | |
| Vancouver Hospital & Health Sciences Centre | |
| Vancouver, British Columbia, Canada, V5Z 1M9 | |
| Canada, Manitoba | |
| St. Boniface General Hospital | |
| Winnipeg, Manitoba, Canada, R2H 2A6 | |
| Canada, Ontario | |
| London Health Sciences Centre | |
| London, Ontario, Canada, N6A 4G5 | |
| Ottawa Hospital | |
| Ottawa, Ontario, Canada, KIY 4E9 | |
| University Health Network | |
| Toronto, Ontario, Canada, M5G 2C4 | |
| Canada, Saskatchewan | |
| St. Paul's Hospital | |
| Saskatoon, Saskatchewan, Canada, S7M 0Z9 | |
Sponsors and Collaborators
Anesiva, Inc.
Investigators
| Study Director: | Todd Lorenz, M.D. | Anesiva, Inc. |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00041925 History of Changes |
| Other Study ID Numbers: | CGT003-03 |
| Study First Received: | July 18, 2002 |
| Last Updated: | July 14, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Anesiva, Inc.:
|
atherosclerotic vascular disease chronic critical limb ischemia neointimal hyperplasia peripheral vein bypass |
infra-inguinal bypass grafting surgery graft stenosis occluded grafts |
Additional relevant MeSH terms:
|
Arterial Occlusive Diseases Graft Occlusion, Vascular Hyperplasia Ischemia Vascular Diseases Peripheral Vascular Diseases |
Peripheral Arterial Disease Cardiovascular Diseases Postoperative Complications Pathologic Processes Atherosclerosis Arteriosclerosis |
ClinicalTrials.gov processed this record on May 23, 2013