Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
184 participants
INTERVENTIONAL
2015-10-19
2019-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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VEST supported
Vein graft supported by VEST
VEST External Support
Coronary Artery Bypass Surgery
Control
Vein grafts unsupported by VEST
Coronary Artery Bypass Surgery
Interventions
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VEST External Support
Coronary Artery Bypass Surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
80 Years
ALL
No
Sponsors
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Vascular Graft Solutions Ltd.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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References
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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.
Other Identifiers
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CD0113
Identifier Type: -
Identifier Source: org_study_id
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