VEST III PMS Clinical Protocol
VEST III
1 other identifier
interventional
184
4 countries
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable coronary-artery-disease
Started Oct 2015
Typical duration for not_applicable coronary-artery-disease
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2015
CompletedFirst Posted
Study publicly available on registry
July 30, 2015
CompletedStudy Start
First participant enrolled
October 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedJune 26, 2020
June 1, 2020
3.6 years
July 25, 2015
June 23, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Intimal hyperplasia area
2 years
MACCE
2 years
Vein graft failure
2 years
Early vein graft failure
6 months
Study Arms (2)
VEST supported
EXPERIMENTALVein graft supported by VEST
Control
ACTIVE COMPARATORVein grafts unsupported by VEST
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Medical University of Innsbruck
Innsbruck, Austria
Medical University of Vienna
Vienna, Austria
German Heart Center
Berlin, Germany
Immanuel Hospital Bernau. Brandenburg Heart Center
Bernau, Germany
University Hospital of Cologne
Cologne, Germany
West-German Heart Center Essen University
Essen, Germany
University Medical Center Schleswig-Holstein
Lübeck, Germany
Krankenhaus der Barmherzigen Bruder
Trier, Germany
Rambam - Health Care Campus
Haifa, Israel
Sheba Medical Center Hospital
Ramat Gan, Israel
Papworth Hospital
Papworth Everard, Cambridge, United Kingdom
Blackpool Victoria Hospital
Blackpool, United Kingdom
University Hospitals Bristol
Bristol, United Kingdom
The John Radcliffe Hospital
Oxford, United Kingdom
University Hospital Southampton
Southampton, United Kingdom
Related Publications (1)
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.
PMID: 29373645DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2015
First Posted
July 30, 2015
Study Start
October 19, 2015
Primary Completion
June 1, 2019
Study Completion
October 1, 2019
Last Updated
June 26, 2020
Record last verified: 2020-06