VEST III PMS Clinical Protocol

Vascular Graft Solutions

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: VEST External Support; Procedure: Coronary Artery Bypass Surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT02511834

CD0113

Details and patient eligibility

About

Post marketing surveillance (PMS) study. 200 patients will be enrolled in a prospective, multi center, randomized, two-arm, open label, and controlled, enrolling patients with multi vessel atherosclerotic coronary artery disease, scheduled to undergo Coronary artery bypass grafting (CABG) with arterial grafting of IMA to LAD, one saphenous vein graft (SVG) to the right territory and one or more SVGs to the left territory. Of all vein grafts, one will be selected randomly to receive treatment with VEST and another designated Control.

Enrollment: 184 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient scheduled for on-pump CABG on clinical grounds
2. Two or more bypass vein grafts bypasses indicated as follows: one (1) for right coronary artery, 1 or more for left coronary arteries and IMA indicated for the LAD on clinical grounds
3. Appropriately sized and accessible target coronary arteries, with a minimum diameter of 1.5 mm and adequate vascular bed
4. Ability to give their informed written consent
5. Ability and willingness to comply with study follow up requirements
6. Patient is ≥ 18 and ≤ 80 years of age, and has Life expectancy ≥5 years

Exclusion criteria

1. Concomitant non-CABG cardiac procedure
2. Prior cardiac surgery
3. Emergency CABG surgery (cardiogenic shock, inotropic pressure support, IABP)
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, before randomization
6. Severe vein varicosity
7. Prior debilitating stroke less than 1 year before surgery
8. Severe renal dysfunction (Cr>2.0 mg/dL or >177 μmol/L)
9. Women of child bearing age
10. Concomitant life-threatening disease likely to limit life expectancy to less than 5 years
11. Indication for Warfarin up to time of surgery
12. Inability to tolerate or comply with required normal post-operative drug regimen (antiplatelet, statin and beta-blockers) that cannot adequately be controlled.
13. inability to take aspirin
14. Contraindication to intravascular contrast material that cannot be adequately controlled with pre-medication
15. Inability to comply with required follow-ups including angiographic and/or CT imaging methods.
16. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

184 participants in 2 patient groups

VEST supported

Experimental group

Description:

Vein graft supported by VEST

Treatment:

Procedure: Coronary Artery Bypass Surgery

Device: VEST External Support

Control

Active Comparator group

Description:

Vein grafts unsupported by VEST

Treatment:

Procedure: Coronary Artery Bypass Surgery