Coronary Artery Disease
Conditions
Keywords
Coronary artery bypass
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.
Interventions
DEVICEVEST
External support for vein grafts, cobalt chrome braid
PROCEDURECoronary artery bypass vein grafts
Bypass coronary arteries with autologous saphenous vein grafts
Sponsors
International Center for Health Outcomes and Innovation Research
Vascular Graft Solutions Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intimal hyperplasia area/graft occlusion | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lumen diameter uniformity | 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 | 1 year | Graft Failure (≥50% stenosis) by cardiac angiography |
Other
| Measure | Time frame | Description |
|---|---|---|
| MACCE | annually over 5 years | Major adverse cardiac and cerebrovascular events |
Countries
Canada, United States
Outcome results
None listed