Study Results
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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COMPLETED
NA
224 participants
INTERVENTIONAL
2018-01-09
2024-09-25
Brief Summary
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Detailed Description
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Coronary artery bypass grafting (CABG) remains the gold standard treatment for patients with multi-vessel coronary artery disease. Despite the proposed benefits of multiple arterial grafts, autologous saphenous vein grafts (SVGs) are still the most frequently used bypass conduits in CABG. Progressive SVG failure after CABG remains a key limitation to the long-term success of surgery.
Objective:
Coronary artery bypass grafting (CABG) remains the gold standard treatment for patients with multi-vessel coronary artery disease. Despite the proposed benefits of multiple arterial grafts, autologous saphenous vein grafts (SVGs) are still the most frequently used bypass conduits in CABG. Progressive SVG failure after CABG remains a key limitation to the long-term success of surgery.
Study design:
Prospective, multi-center, randomized, within-subject-controlled , trial, enrolling patients with multi vessel atherosclerotic coronary artery disease, scheduled to undergo SVG CABG with arterial grafting of IMA to LAD and two or more saphenous vein grafts. In each patient, one SVG bypass will be randomized to be supported by the VEST, while another will not be supported and serve as control. Thus, the full cohort will provide a basis for comparison between two sets of SVGs: A VEST supported set; and an unsupported set.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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VEST supported vein graft
Coronary artery bypass vein graft supported with the VEST implant
VEST
External support for vein grafts, cobalt chrome braid
Coronary artery bypass vein grafts
Bypass coronary arteries with autologous saphenous vein grafts
Standard of care vein grafts
Coronary artery bypass vein grafts
Coronary artery bypass vein grafts
Bypass coronary arteries with autologous saphenous vein grafts
Interventions
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VEST
External support for vein grafts, cobalt chrome braid
Coronary artery bypass vein grafts
Bypass coronary arteries with autologous saphenous vein grafts
Eligibility Criteria
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Inclusion Criteria
2. Age 21 years or older.
3. Planned and scheduled on-pump CABG.
4. Two or more vein grafts to native vessels having at least 75% stenosis and comparable runoff.
5. IMA graft indicated for the LAD. Additional arterial grafts may be considered based on practice guidelines.
6. Appropriately sized and accessible target coronary arteries, with a minimum diameter of 1.5 mm and adequate vascular bed (without significant distal stenosis), as assessed by pre-operative cardiac angiography and verified by diameter gauging intraoperatively.
Exclusion Criteria
2. Prior cardiac surgery.
3. Emergency CABG surgery.
4. Contraindication for on-pump CABG with cardioplegic arrest (e.g. severely calcified aorta).
5. Calcification at the intended anastomotic sites, as assessed upon opening of the chest and before randomization.
6. Severe vein varicosity as assessed after vein harvesting and before randomization.
7. History of clinical stroke within 3 months prior to randomization.
8. Severe renal dysfunction (Cr\>2.0 mg/dL).
9. Documented or suspected untreated diffuse peripheral vascular disease such as: carotid stenosis or claudication of the extremities.
10. Concomitant life-threatening disease likely to limit life expectancy to less than two years.
11. Inability to tolerate or comply with required guideline-based post-operative drug regimen (antiplatelet plus statin) and/or inability to take aspirin.
12. Inability to comply with required follow-ups including angiographic imaging methods (e.g. contrast allergy).
13. Concurrent participation in an interventional (drug or device) trial.
21 Years
ALL
No
Sponsors
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International Center for Health Outcomes and Innovation Research
OTHER
Vascular Graft Solutions Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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John Puskas, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Daniel Goldstein, MD
Role: PRINCIPAL_INVESTIGATOR
Montefiore Medical Center
Locations
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University of Southern California
Los Angeles, California, United States
Lutheran Hospital of Indiana
Fort Wayne, Indiana, United States
University of Maryland Baltimore
Baltimore, Maryland, United States
Mayo Clinic
Rochester, Minnesota, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Mount Sinai St Luke's
New York, New York, United States
New York Presbyterian Hospital/Columbia University Medical Center
New York, New York, United States
Montefiore Medical Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
WakeMed Health & Hospitals
Raleigh, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Baylor Scott & White Research Institute, The Heart Hospital Baylor Plano
Plano, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
London Health Sciences Centre, University Hospital
London, Ontario, Canada
Institut de Cardiologie de Montréal
Montreal, Quebec, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec - Université Laval
Québec, Quebec, Canada
Countries
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References
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Goldstein DJ, Puskas JD, Alexander JH, Chang HL, Gammie JS, Marks ME, Iribarne A, Vengrenyuk Y, Raymond S, Taylor BS, Yarden O, Orion E, Dagenais F, Ailawadi G, Chu MWA, DiMaio JM, Narula J, Moquete EG, O'Sullivan K, Williams JB Jr, Crestanello JA, Jessup M, Rose EA, Scavo V, Acker MA, Gillinov M, Mack MJ, Gelijns AC, O'Gara PT, Moskowitz AJ, Bagiella E, Voisine P. External Support for Saphenous Vein Grafts in Coronary Artery Bypass Surgery: A Randomized Clinical Trial. JAMA Cardiol. 2022 Aug 1;7(8):808-816. doi: 10.1001/jamacardio.2022.1437.
Other Identifiers
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CD0131
Identifier Type: -
Identifier Source: org_study_id
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