VEST III PMS Clinical Protocol
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT02511834
- Lead Sponsor
- Vascular Graft Solutions Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 184
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Proportion of Vein grafts with Fitzgibbon I patency score out of all grafts including occluded ones. 2 years Perfect patency, no lumen irregularities. Rates out of all grafts including occluded ones.
- Secondary Outcome Measures
Name Time Method MACCE 2 years Composite of: All-cause mortality; Stroke; Myocardial infarction; Coronary revascularization
Vein graft failure 2 years Defined as ≥50% stenosis by QCA
Early vein graft failure 6 months Early vein graft failure, defined as \>50% occlusion by CT Angio
Intimal hyperplasia area 2 years Sub group (IVUS) - Intimal hyperplasia (plaque+media) area \[mm2\] as assessed by IVUS
Trial Locations
- Locations (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
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