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VEST Venous Graft External Support Pivotal Study — VEST Pivotal  

Coronary Artery Disease Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03209609
Study type Interventional
Source Vascular Graft Solutions Ltd.
Contact
Status Active, not recruiting
Phase N/A
Start date January 9, 2018
Completion date June 1, 2024
View Details
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