Prevention of Autogenous Vein Graft Failure in Peripheral Artery Bypass Procedures

This study has been completed.
Sponsor:
Information provided by:
Anesiva, Inc.
ClinicalTrials.gov Identifier:
NCT00041925
First received: July 18, 2002
Last updated: July 14, 2005
Last verified: July 2005
  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
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00041925

  Show 123 Study Locations
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 July 29, 2014