VEST Venous Graft External Support Pivotal Study
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-001656
NCT ID: NCT03209609
Sponsor Protocol Number: CD0131
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- 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: 1 for the right coronary artery, 1 or more for the left coronary arteries, with native vessels having at least 75% stenosis.
- IMA graft indicated for the LAD and additional arterial graft considered based on practice guidelines. A patient who is candidate for one, two, or more arterial grafts would only be eligible if in addition to the arterial grafts at least two vein grafts are used as specified above.
- 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.
Exclusion Criteria:
- Concomitant non-CABG cardiac surgical procedure.
- Prior cardiac surgery.
- Emergency CABG surgery (cardiogenic shock, inotropic pressure support, IABP).
- 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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Juan Crestanello, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available