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NCT00041925

Prevention of Autogenous Vein Graft Failure in Peripheral Artery Bypass Procedures

NCT ID: NCT00041925

Last Updated: 2005-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

1400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Study Completion Date

2004-11-30

Brief Summary

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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

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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.

Conditions

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

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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CGT003 (E2F Duplex Decoy)

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Principal Investigators

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Todd Lorenz, M.D.

Role: STUDY_DIRECTOR

Anesiva, Inc.

Locations

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The Kirklin Clinic

Birmingham, Alabama, United States

Site Status

University Hospital

Birmingham, Alabama, United States

Site Status

Mobile Infirmary Medical Center

Mobile, Alabama, United States

Site Status

Vascular Specialists of Mobile, PC

Mobile, Alabama, United States

Site Status