VEST Venous Graft External Support Pivotal Study

Completed · Not applicable

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT03209609

Run by

Vascular Graft Solutions Ltd.

People needed

224

Starts

2018-01-09

Expected to finish

2024-09-25

Last updated by the study team

2025-02-06

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent, inclusive of release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documentation.
• Age 21 years or older.
• Planned and scheduled on-pump CABG.
• Two or more vein grafts to native vessels having at least 75% stenosis and comparable runoff.
• IMA graft indicated for the LAD. Additional arterial grafts may be considered based on practice guidelines.
• 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.

You may not qualify if…

• Concomitant non-CABG cardiac surgical procedure.
• Prior cardiac surgery.
• Emergency CABG surgery.
• Contraindication for on-pump CABG with cardioplegic arrest (e.g. severely calcified aorta).
• Calcification at the intended anastomotic sites, as assessed upon opening of the chest and before randomization.
• Severe vein varicosity as assessed after vein harvesting and before randomization.
• History of clinical stroke within 3 months prior to randomization.
• Severe renal dysfunction (Cr>2.0 mg/dL).
• Documented or suspected untreated diffuse peripheral vascular disease such as: carotid stenosis or claudication of the extremities.
• Concomitant life-threatening disease likely to limit life expectancy to less than two years.
• Inability to tolerate or comply with required guideline-based post-operative drug regimen (antiplatelet plus statin) and/or inability to take aspirin.
• Inability to comply with required follow-ups including angiographic imaging methods (e.g. contrast allergy).
• Concurrent participation in an interventional (drug or device) trial.

Where it is running

• 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

Full record on ClinicalTrials.gov

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