Prevention of Autogenous Vein Graft Failure in Peripheral Artery Bypass Procedures
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| ClinicalTrials.gov Identifier: NCT00041925 |
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Recruitment Status :
Completed
First Posted : July 22, 2002
Last Update Posted : July 15, 2005
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| 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 |
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.
| 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 |
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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 ClinicalTrials.gov identifier (NCT number): NCT00041925
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| Study Director: | Todd Lorenz, M.D. | Anesiva, Inc. |
| ClinicalTrials.gov 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 |
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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 |
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Vascular Diseases Peripheral Vascular Diseases Peripheral Arterial Disease Arterial Occlusive Diseases Ischemia Hyperplasia |
Graft Occlusion, Vascular Pathologic Processes Cardiovascular Diseases Atherosclerosis Arteriosclerosis Postoperative Complications |