VEST III PMS Clinical Protocol

Coronary Artery Disease Clinical Trial

— VEST III  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02511834
• Other study ID #: CD0113
• Status: Completed
• Phase: N/A
• Start date: October 19, 2015
• Est. completion date: October 2019

Study information

• Verified date: June 2020
• Source: Vascular Graft Solutions Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: October 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• VEST External Support

Procedure:
• Coronary Artery Bypass Surgery

Locations

Country	Name	City	State
Austria	Medical University of Innsbruck	Innsbruck
Austria	Medical University of Vienna	Vienna
Germany	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
Israel	Rambam - Health Care Campus	Haifa
Israel	Sheba Medical Center Hospital	Ramat Gan
United Kingdom	Blackpool Victoria Hospital	Blackpool
United Kingdom	University Hospitals Bristol	Bristol
United Kingdom	The John Radcliffe Hospital	Oxford
United Kingdom	Papworth Hospital	Papworth Everard	Cambridge
United Kingdom	University Hospital Southampton	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
Vascular Graft Solutions Ltd.

Countries where clinical trial is conducted

Austria,  Germany,  Israel,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Intimal hyperplasia area	Sub group (IVUS) - Intimal hyperplasia (plaque+media) area [mm2] as assessed by IVUS	2 years
Secondary	MACCE	Composite of: All-cause mortality; Stroke; Myocardial infarction; Coronary revascularization	2 years
Secondary	Vein graft failure	Defined as =50% stenosis by QCA	2 years
Secondary	Early vein graft failure	Early vein graft failure, defined as >50% occlusion by CT Angio	6 months