An interventional study of VEST and Coronary artery bypass vein grafts in Coronary Artery Disease, sponsored by Vascular Graft Solutions Ltd.. Completed at 17 sites in 2 countries. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-02-06.
Sponsored by Vascular Graft Solutions Ltd. · Not applicable, Interventional, and Prevention
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.
5,677 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.
This study's enrollment of 224 is above the median of 123 across 3,481 interventional studies indexed under Coronary Artery Disease.
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Exclusion Criteria:
Coronary artery bypass vein graft supported with the VEST implant
Device: VEST · Procedure: Coronary artery bypass vein grafts
Coronary artery bypass vein grafts
Procedure: Coronary artery bypass vein grafts
External support for vein grafts, cobalt chrome braid
Bypass coronary arteries with autologous saphenous vein grafts
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
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
MACCE
Major adverse cardiac and cerebrovascular events
Time frame: annually over 5 years
Plan to share: No
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Vascular Graft Solutions Ltd.