VEST Venous Graft External Support Pivotal Study (VEST Pivotal)

• ClinicalTrials.gov Identifier: NCT03209609
• Recruitment Status: Active, not recruiting
• First Posted: July 6, 2017
• Last Update Posted: October 8, 2020
• Sponsor: Vascular Graft Solutions Ltd.
• Collaborator: International Center for Health Outcomes and Innovation Research
• Information provided by (Responsible Party): Vascular Graft Solutions Ltd.

Tracking Information

• First Submitted Date: July 4, 2017
• First Posted Date: July 6, 2017
• Last Update Posted Date: October 8, 2020
• Actual Study Start Date: January 9, 2018
• Estimated Primary Completion Date: November 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 4, 2017)

Intimal hyperplasia area/graft occlusion [ Time Frame: 1 year ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 4, 2017)

• Lumen diameter uniformity [ Time Frame: 1 year ]
  Lumen diameter uniformity, assessed by angiography for each graft separately and expressed by the Fitzgibbon classification (22), on a 3-point ordinal scale
• vein graft failure [ Time Frame: 1 year ]
  Graft Failure (≥50% stenosis) by cardiac angiography

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: July 4, 2017)

MACCE [ Time Frame: annually over 5 years ]

Major adverse cardiac and cerebrovascular events

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: VEST Venous Graft External Support Pivotal Study
• Official Title: A Multi-center, Randomized, Within-subject-controlled, Open Label Study of the Safety and Effectiveness of VEST, Venous External Support
• 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.

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
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.

Masking: None (Open Label)
Primary Purpose: Prevention

• Condition: Coronary Artery Disease

Intervention

• Device: VEST
  External support for vein grafts, cobalt chrome braid
• Procedure: Coronary artery bypass vein grafts
  Bypass coronary arteries with autologous saphenous vein grafts

Study Arms

• Experimental: VEST supported vein graft
  Coronary artery bypass vein graft supported with the VEST implant
  Interventions:

  • Device: VEST
  • Procedure: Coronary artery bypass vein grafts
• Active Comparator: Standard of care vein grafts
  Coronary artery bypass vein grafts
  Intervention: Procedure: Coronary artery bypass vein grafts

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: July 4, 2017): 224
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 1, 2024
• Estimated Primary Completion Date: November 1, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, United States

Administrative Information

• NCT Number: NCT03209609
• Other Study ID Numbers: CD0131
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Vascular Graft Solutions Ltd.
• Study 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

• PRS Account: Vascular Graft Solutions Ltd.
• Verification Date: May 2020