VEST III PMS Clinical Protocol

Study Overview
=================
Brief Summary
-----------------
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.

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: VEST External Support
* Procedure: Coronary Artery Bypass Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient scheduled for on-pump CABG on clinical grounds 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 Appropriately sized and accessible target coronary arteries, with a minimum diameter of 1.5 mm and adequate vascular bed Ability to give their informed written consent Ability and willingness to comply with study follow up requirements Patient is ≥ 18 and ≤ 80 years of age, and has Life expectancy ≥5 years Exclusion Criteria: Concomitant non-CABG cardiac 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, before randomization Severe vein varicosity Prior debilitating stroke less than 1 year before surgery Severe renal dysfunction (Cr>2.0 mg/dL or >177 μmol/L) Women of child bearing age Concomitant life-threatening disease likely to limit life expectancy to less than 5 years Indication for Warfarin up to time of surgery Inability to tolerate or comply with required normal post-operative drug regimen (antiplatelet, statin and beta-blockers) that cannot adequately be controlled. inability to take aspirin Contraindication to intravascular contrast material that cannot be adequately controlled with pre-medication Inability to comply with required follow-ups including angiographic and/or CT imaging methods. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VEST supported<br>Vein graft supported by VEST | Device: VEST External Support<br> <br> Procedure: Coronary Artery Bypass Surgery<br> <br> * Other names: CABG;|
| Active Comparator: Control<br>Vein grafts unsupported by VEST | Procedure: Coronary Artery Bypass Surgery<br> <br> * Other names: CABG;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Vein grafts with Fitzgibbon I patency score out of all grafts including occluded ones. | Perfect patency, no lumen irregularities. Rates out of all grafts including occluded ones. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intimal hyperplasia area | Sub group (IVUS) - Intimal hyperplasia (plaque+media) area [mm2] as assessed by IVUS | 2 years | 
| MACCE | Composite of: All-cause mortality; Stroke; Myocardial infarction; Coronary revascularization | 2 years | 
| Vein graft failure | Defined as ≥50% stenosis by QCA | 2 years | 
| Early vein graft failure | Early vein graft failure, defined as >50% occlusion by CT Angio | 6 months |