VEST Venous Graft External Support Pivotal Study (VEST Pivotal)

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

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 Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: VEST; Procedure: Coronary artery bypass vein grafts

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.

• Study Type: Interventional
• Enrollment (Actual): 224
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre, University Hospital
  • Quebec
    • Montréal, Quebec, Canada, H1T 1C8
      • Institut de Cardiologie de Montreal
    • Québec City, Quebec, Canada, G1V 4G5
      • Institut universitaire de cardiologie et de pneumologie de Quebec - Universite Laval
• United States
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Lutheran Hospital of Indiana
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Baltimore
  • Minnesota
    • Rochester, Minnesota, United States, 55902
      • Mayo Clinic
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center
  • New York
    • New York, New York, United States, 10467
      • Montefiore Medical Center
    • New York, New York, United States, 10025
      • Mount Sinai St Luke's
    • New York, New York, United States, 10032
      • New York Presbyterian Hospital/Columbia University Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center
    • Raleigh, North Carolina, United States, 27610
      • WakeMed Health & Hospitals
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
  • Texas
    • Plano, Texas, United States, 75093
      • Baylor Scott & White Research Institute, The Heart Hospital Baylor Plano
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Signed informed consent, inclusive of release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documentation.
2. Age 21 years or older.
3. Planned and scheduled on-pump CABG.
4. Two or more vein grafts to native vessels having at least 75% stenosis and comparable runoff.
5. IMA graft indicated for the LAD. Additional arterial grafts may be considered based on practice guidelines.
6. 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VEST supported vein graft; Coronary artery bypass vein graft supported with the VEST implant	Device: VEST; External support for vein grafts, cobalt chrome braid; Procedure: Coronary artery bypass vein grafts; Bypass coronary arteries with autologous saphenous vein grafts
Active Comparator: Standard of care vein grafts; Coronary artery bypass vein grafts	Procedure: Coronary artery bypass vein grafts; Bypass coronary arteries with autologous saphenous vein grafts

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year
vein graft failure	Graft Failure (≥50% stenosis) by cardiac angiography	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACCE	Major adverse cardiac and cerebrovascular events	annually over 5 years

Collaborators and Investigators

• Sponsor: Vascular Graft Solutions Ltd.
• Collaborators: International Center for Health Outcomes and Innovation Research
• Investigators: Principal Investigator: John Puskas, MD, ICAHN School of Medicine at Mount Sinai; Principal Investigator: Daniel Goldstein, MD, Montefiore Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2018
• Primary Completion (Actual): September 29, 2020
• Study Completion (Actual): September 25, 2024

Study Registration Dates

• First Submitted: July 4, 2017
• First Submitted That Met QC Criteria: July 4, 2017
• First Posted (Actual): July 6, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Coronary artery bypass
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: CD0131

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No