VEST Venous Graft External Support Pivotal Study

NCT03209609 | Completed DMC FDA Device

• 1 other identifier: CD0131
• Study Type: interventional
• Target: 224
• Locations: 2 countries
• Sites: 17

Brief 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

Coronary Artery Disease

Keywords

Coronary artery bypass

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Secondary Outcomes (2)

• Lumen diameter uniformity

  1 year

• vein graft failure

  1 year

Other Outcomes (1)

• MACCE

  annually over 5 years

Study Arms (2)

VEST supported vein graft

EXPERIMENTAL

Coronary artery bypass vein graft supported with the VEST implant

Device: VEST; Procedure: Coronary artery bypass vein grafts

Standard of care vein grafts

ACTIVE COMPARATOR

Coronary artery bypass vein grafts

Procedure: Coronary artery bypass vein grafts

Interventions

VEST DEVICE

External support for vein grafts, cobalt chrome braid

VEST supported vein graft

Coronary artery bypass vein grafts PROCEDURE

Bypass coronary arteries with autologous saphenous vein grafts

Standard of care vein grafts; VEST supported vein graft

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent, inclusive of release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documentation.
• Age 21 years or older.
• Planned and scheduled on-pump CABG.
• Two or more vein grafts to native vessels having at least 75% stenosis and comparable runoff.
• IMA graft indicated for the LAD. Additional arterial grafts may be considered based on practice guidelines.
• 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.

You may not qualify if:

• Concomitant non-CABG cardiac surgical procedure.
• Prior cardiac surgery.
• Emergency CABG surgery.
• Contraindication for on-pump CABG with cardioplegic arrest (e.g. severely calcified aorta).
• Calcification at the intended anastomotic sites, as assessed upon opening of the chest and before randomization.
• Severe vein varicosity as assessed after vein harvesting and before randomization.
• History of clinical stroke within 3 months prior to randomization.
• Severe renal dysfunction (Cr\>2.0 mg/dL).
• Documented or suspected untreated diffuse peripheral vascular disease such as: carotid stenosis or claudication of the extremities.
• Concomitant life-threatening disease likely to limit life expectancy to less than two years.
• Inability to tolerate or comply with required guideline-based post-operative drug regimen (antiplatelet plus statin) and/or inability to take aspirin.
• Inability to comply with required follow-ups including angiographic imaging methods (e.g. contrast allergy).
• Concurrent participation in an interventional (drug or device) trial.

Sponsors & Collaborators

• Vascular Graft Solutions Ltd.: lead
• International Center for Health Outcomes and Innovation Research: collaborator

Study Sites (17)

University of Southern California

Los Angeles, California, 90033, United States

Location

Lutheran Hospital of Indiana

Fort Wayne, Indiana, 46804, United States

Location

University of Maryland Baltimore

Baltimore, Maryland, 21201, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Mount Sinai St Luke's

New York, New York, 10025, United States

Location

New York Presbyterian Hospital/Columbia University Medical Center

New York, New York, 10032, United States

Location

Montefiore Medical Center

New York, New York, 10467, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

WakeMed Health & Hospitals

Raleigh, North Carolina, 27610, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Baylor Scott & White Research Institute, The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

London Health Sciences Centre, University Hospital

London, Ontario, N6A 5A5, Canada

Location

Institut de Cardiologie de Montréal

Montreal, Quebec, H1T 1C8, Canada

Location

Institut Universitaire de Cardiologie et de Pneumologie de Québec - Université Laval

Québec, Quebec, G1V 4G5, Canada

Location

Related Publications (1)

• Goldstein DJ, Puskas JD, Alexander JH, Chang HL, Gammie JS, Marks ME, Iribarne A, Vengrenyuk Y, Raymond S, Taylor BS, Yarden O, Orion E, Dagenais F, Ailawadi G, Chu MWA, DiMaio JM, Narula J, Moquete EG, O'Sullivan K, Williams JB Jr, Crestanello JA, Jessup M, Rose EA, Scavo V, Acker MA, Gillinov M, Mack MJ, Gelijns AC, O'Gara PT, Moskowitz AJ, Bagiella E, Voisine P. External Support for Saphenous Vein Grafts in Coronary Artery Bypass Surgery: A Randomized Clinical Trial. JAMA Cardiol. 2022 Aug 1;7(8):808-816. doi: 10.1001/jamacardio.2022.1437.

  PMID: 35675092 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• John Puskas, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Daniel Goldstein, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 4, 2017
• First Posted: July 6, 2017
• Study Start: January 9, 2018
• Primary Completion: September 29, 2020
• Study Completion: September 25, 2024
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3); US (14)