VEST Venous Graft External Support Pivotal Study

N/ACompletedNCT03209609

Vascular Graft Solutions Ltd.224 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

224

Conditions

Coronary Artery Disease

Interventions

VESTDEVICE

External support for vein grafts, cobalt chrome braid

Coronary artery bypass vein graftsPROCEDURE

Bypass coronary arteries with autologous saphenous vein grafts

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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.

Locations (17)

University of Southern California

Los Angeles, California, United States

Lutheran Hospital of Indiana

Fort Wayne, Indiana, United States

Outcomes

Primary Outcomes

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

Time frame: 1 year

Secondary Outcomes

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

Time frame: 1 year

vein graft failure

Graft Failure (≥50% stenosis) by cardiac angiography

Time frame: 1 year

Data from ClinicalTrials.gov

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