VEST III PMS Clinical Protocol

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: VEST External Support; Procedure: Coronary Artery Bypass Surgery

• 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

Study Timeline

• Study First Submitted: 2015-07-25
• Study First Submitted QC: 2015-07-27
• Study First Posted: 2015-07-30
• Study Start: 2015-10-19
• Primary Completion: 2019-06
• Study Completion: 2019-10
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-23
• Last Update Posted: 2020-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VEST supported	Coronary Artery Bypass Surgery	Vein graft supported by VEST
Control	Coronary Artery Bypass Surgery	Vein grafts unsupported by VEST
VEST supported	VEST External Support	Vein graft supported by VEST

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

University Hospital of Cologne; 🇩🇪 Cologne, Germany

Immanuel Hospital Bernau. Brandenburg Heart Center; 🇩🇪 Bernau, Germany

German Heart Center; 🇩🇪 Berlin, Germany

University Medical Center Schleswig-Holstein; 🇩🇪 Lübeck, Germany

West-German Heart Center Essen University; 🇩🇪 Essen, Germany

Krankenhaus der Barmherzigen Bruder; 🇩🇪 Trier, Germany

Rambam - Health Care Campus; 🇮🇱 Haifa, Israel

The John Radcliffe Hospital; 🇬🇧 Oxford, United Kingdom

Sheba Medical Center Hospital; 🇮🇱 Ramat Gan, Israel

Blackpool Victoria Hospital; 🇬🇧 Blackpool, United Kingdom

University Hospitals Bristol; 🇬🇧 Bristol, United Kingdom

University Hospital Southampton; 🇬🇧 Southampton, United Kingdom

Papworth Hospital; 🇬🇧 Papworth Everard, Cambridge, United Kingdom