VEST III PMS Clinical Protocol (VEST III)

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: VEST External Support; Procedure: Coronary Artery Bypass Surgery

• Study Type: Interventional
• Enrollment (Actual): 184
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria
    • Medical University of Innsbruck
  • Vienna, Austria
    • Medical University of Vienna
• Germany
  • Berlin, Germany
    • German Heart Center
  • Bernau, Germany
    • Immanuel Hospital Bernau. Brandenburg Heart Center
  • Cologne, Germany
    • University Hospital of Cologne
  • Essen, Germany
    • West-German Heart Center Essen University
  • Lübeck, Germany
    • University Medical Center Schleswig-Holstein
  • Trier, Germany
    • Krankenhaus der Barmherzigen Brüder
• Israel
  • Haifa, Israel
    • Rambam - health care campus
  • Ramat Gan, Israel
    • Sheba Medical center Hospital
• United Kingdom
  • Blackpool, United Kingdom
    • Blackpool Victoria Hospital
  • Bristol, United Kingdom
    • University Hospitals Bristol
  • Oxford, United Kingdom
    • The John Radcliffe Hospital
  • Southampton, United Kingdom
    • University Hospital Southampton
  • Cambridge
    • Papworth Everard, Cambridge, United Kingdom
      • Papworth Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VEST supported; Vein graft supported by VEST	Device: VEST External Support; Procedure: Coronary Artery Bypass Surgery; Other Names: CABG
Active Comparator: Control; Vein grafts unsupported by VEST	Procedure: Coronary Artery Bypass Surgery; 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

Collaborators and Investigators

• Sponsor: Vascular Graft Solutions Ltd.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2015
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: July 25, 2015
• First Submitted That Met QC Criteria: July 27, 2015
• First Posted (Estimate): July 30, 2015

Study Record Updates

• Last Update Posted (Actual): June 26, 2020
• Last Update Submitted That Met QC Criteria: June 23, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: CD0113