VEST Venous Graft External Support Pivotal Study

Coronary Artery Disease Clinical Trial

— VEST Pivotal  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03209609
• Other study ID #: CD0131
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 9, 2018
• Est. completion date: June 1, 2024

Study information

• Verified date: May 2023
• Source: Vascular Graft Solutions Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 224
• Est. completion date: June 1, 2024
• Est. primary completion date: September 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• 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

Locations

Country	Name	City	State
Canada	London Health Sciences Centre, University Hospital	London	Ontario
Canada	Institut de Cardiologie de Montréal	Montréal	Quebec
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Québec - Université Laval	Québec City	Quebec
United States	University of Maryland Baltimore	Baltimore	Maryland
United States	University of Virginia	Charlottesville	Virginia
United States	Cleveland Clinic	Cleveland	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Lutheran Hospital of Indiana	Fort Wayne	Indiana
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	University of Southern California	Los Angeles	California
United States	Montefiore Medical Center	New York	New York
United States	Mount Sinai St Luke's	New York	New York
United States	New York Presbyterian Hospital/Columbia University Medical Center	New York	New York
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Baylor Scott & White Research Institute, The Heart Hospital Baylor Plano	Plano	Texas
United States	WakeMed Health & Hospitals	Raleigh	North Carolina
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Vascular Graft Solutions Ltd.	International Center for Health Outcomes and Innovation Research

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	MACCE	Major adverse cardiac and cerebrovascular events	annually over 5 years
Primary	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	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
Secondary	vein graft failure	Graft Failure (=50% stenosis) by cardiac angiography	1 year