VEST Venous Graft External Support Pivotal Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multi-center, Randomized, Within-subject-controlled, Open Label Study of the Safety and Effectiveness of VEST, Venous External Support

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: VEST
* Procedure: Coronary artery bypass vein grafts


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VEST supported vein graft<br>Coronary artery bypass vein graft supported with the VEST implant | Device: VEST<br>* External support for vein grafts, cobalt chrome braid<br>Procedure: Coronary artery bypass vein grafts<br>* Bypass coronary arteries with autologous saphenous vein grafts<br>|
| Active Comparator: Standard of care vein grafts<br>Coronary artery bypass vein grafts | Procedure: Coronary artery bypass vein grafts<br>* Bypass coronary arteries with autologous saphenous vein grafts<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intimal hyperplasia area/graft occlusion | 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 | 1 year | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary artery bypass