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Prevention of Autogenous Vein Graft Failure in Peripheral Artery Bypass Procedures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00041925
Recruitment Status : Completed
First Posted : July 22, 2002
Last Update Posted : July 15, 2005
Information provided by:
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).

Condition or disease Intervention/treatment Phase
Peripheral Vascular Diseases Arterial Occlusive Diseases Ischemia Graft Occlusion, Vascular Hyperplasia Drug: CGT003 (E2F Duplex Decoy) Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 1400 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
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
Study Start Date : November 2001
Study Completion Date : November 2004

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00041925

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Sponsors and Collaborators
Anesiva, Inc.
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Study Director: Todd Lorenz, M.D. Anesiva, Inc.
Layout table for additonal information Identifier: NCT00041925    
Other Study ID Numbers: CGT003-03
First Posted: July 22, 2002    Key Record Dates
Last Update Posted: July 15, 2005
Last Verified: July 2005
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:
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Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Arterial Occlusive Diseases
Graft Occlusion, Vascular
Pathologic Processes
Cardiovascular Diseases
Postoperative Complications