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VEST Venous Graft External Support Pivotal Study

NCT03209609 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2025-02-06

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

VEST

External support for vein grafts, cobalt chrome braid

PROCEDURE

Coronary artery bypass vein grafts

Bypass coronary arteries with autologous saphenous vein grafts

Sponsors & Collaborators

  • International Center for Health Outcomes and Innovation Research

    collaborator OTHER

  • Vascular Graft Solutions Ltd.

    lead INDUSTRY

Principal Investigators

  • John Puskas, MD · Icahn School of Medicine at Mount Sinai

  • Daniel Goldstein, MD · Montefiore Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-09
Primary Completion
2020-09-29
Completion
2024-09-25
FDA Device
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03209609 on ClinicalTrials.gov