NCT03209609

VEST Venous Graft External Support Pivotal Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: Vascular Graft Solutions Ltd. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	VEST	External support for vein grafts, cobalt chrome braid
PROCEDURE	Coronary artery bypass vein grafts	Bypass coronary arteries with autologous saphenous vein grafts

Timeline

• Start date: 2018-01-09
• Primary completion: 2020-09-29
• Completion: 2024-09-25
• First posted: 2017-07-06
• Last updated: 2025-02-06

Locations

17 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study