Clinical trial NCT02511834: VEST III PMS Clinical Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Vascular Graft Solutions Ltd.
Sponsor class: INDUSTRY
First posted: 2015-07-30
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of Vein grafts with Fitzgibbon I patency score out of all grafts including occluded ones.
timeFrame: 2 years
Secondary outcomes:
measure: Intimal hyperplasia area
timeFrame: 2 years
measure: MACCE
timeFrame: 2 years
measure: Vein graft failure
timeFrame: 2 years
measure: Early vein graft failure
timeFrame: 6 months
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Berlin
country: Germany
facility: German Heart Center
city: Bernau
country: Germany
facility: Immanuel Hospital Bernau. Brandenburg Heart Center
city: Cologne
country: Germany
facility: University Hospital of Cologne
city: Essen
country: Germany
facility: West-German Heart Center Essen University
city: Lübeck
country: Germany
facility: University Medical Center Schleswig-Holstein
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Bruder
city: Haifa
country: Israel
facility: Rambam - Health Care Campus
city: Ramat Gan
country: Israel
facility: Sheba Medical Center Hospital
city: Papworth Everard
country: United Kingdom
facility: Papworth Hospital
state: Cambridge
city: Blackpool
country: United Kingdom
facility: Blackpool Victoria Hospital
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol
city: Oxford
country: United Kingdom
facility: The John Radcliffe Hospital
city: Southampton
country: United Kingdom
facility: University Hospital Southampton
Study officials:
References:
citation: Amin S, Werner RS, Madsen PL, Krasopoulos G, Taggart DP. Influence of external stenting on venous graft flow parameters in coronary artery bypass grafting: a randomized study. Interact Cardiovasc Thorac Surg. 2018 Jun 1;26(6):926-931. doi: 10.1093/icvts/ivy007.