VEST Venous Graft External Support Pivotal Study

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Procedure: Coronary artery bypass vein grafts; Device: VEST

• Registration Number: NCT03209609
• Lead Sponsor: Vascular Graft Solutions Ltd.

Brief Summary

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.

Detailed Description

Clinical significance:

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.

Study Timeline

• Study First Submitted: 2017-07-04
• Study First Submitted QC: 2017-07-04
• Study First Posted: 2017-07-06
• Study Start: 2018-01-09
• Primary Completion: 2020-09-29
• Study Completion: 2024-09-25
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

Inclusion Criteria

1. Signed informed consent, inclusive of release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documentation.
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

1. Concomitant non-CABG cardiac surgical procedure.
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care vein grafts	Coronary artery bypass vein grafts	Coronary artery bypass vein grafts
VEST supported vein graft	Coronary artery bypass vein grafts	Coronary artery bypass vein graft supported with the VEST implant
VEST supported vein graft	VEST	Coronary artery bypass vein graft supported with the VEST implant

Primary Outcome Measures

Name	Time	Method
Intimal hyperplasia area/graft occlusion	1 year	Intimal hyperplasia (plaque+media) area \[mm2\] as assessed by IVUS at 12 months. Occluded vessels are accounted for in the analysis of the primary endpoint

Secondary Outcome Measures

Name	Time	Method
vein graft failure	1 year	Graft Failure (≥50% stenosis) by cardiac angiography
Lumen diameter uniformity	1 year	Lumen diameter uniformity, assessed by angiography for each graft separately and expressed by the Fitzgibbon classification (22), on a 3-point ordinal scale

Trial Locations

Locations (17)

Institut de Cardiologie de Montréal; 🇨🇦 Montréal, Quebec, Canada

London Health Sciences Centre, University Hospital; 🇨🇦 London, Ontario, Canada

WakeMed Health & Hospitals; 🇺🇸 Raleigh, North Carolina, United States

Institut Universitaire de Cardiologie et de Pneumologie de Québec - Université Laval; 🇨🇦 Québec City, Quebec, Canada

New York Presbyterian Hospital/Columbia University Medical Center; 🇺🇸 New York, New York, United States

Lutheran Hospital of Indiana; 🇺🇸 Fort Wayne, Indiana, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

University of Maryland Baltimore; 🇺🇸 Baltimore, Maryland, United States

Mount Sinai St Luke's; 🇺🇸 New York, New York, United States

University of Southern California; 🇺🇸 Los Angeles, California, United States

Baylor Scott & White Research Institute, The Heart Hospital Baylor Plano; 🇺🇸 Plano, Texas, United States

Montefiore Medical Center; 🇺🇸 New York, New York, United States