CD0104 VEST II Post Marketing Surveillance Study

Not Applicable

Completed

• Conditions: Coronary Artery Bypass Surgery
• Interventions: Device: VEST

• Registration Number: NCT02332330
• Lead Sponsor: Vascular Graft Solutions Ltd.

Brief Summary

This study is designed to collect post market data on use of the VEST, particularly on saphenous vein grafts to the right territory of the heart.

Detailed Description

The primary objective is to test the early-mid term patency rate of VEST supported Right Coronary Artery (RCA) bypass grafts. The research participants will undergo CABG preparations and CABG procedure routinely as is the standard of care. During the procedure the VEST will be implanted on the vein graft to the Right Coronary Artery according to the IFU. Perioperative care is according to standard of care. Upon discharge patient will be prescribed statins and aspirin for 6 months. Patient will attend a routine clinic visit 4-6 weeks post operatively. The last study visit will occur 3-6 months post operatively. Patients will undergo a noninvasive coronary CT angiography.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-04
• Study First Submitted QC: 2015-01-04
• Study First Posted: 2015-01-06
• Status Verified: 2015-10
• Primary Completion: 2016-01
• Study Completion: 2016-04
• Last Update Submitted: 2016-04-27
• Last Update Posted: 2016-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Patient scheduled for on-pump CABG on clinical grounds
2. At least one vein graft bypass indicated for right coronary artery and LIMA 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, as assessed from the pre-operative cardiac angiography.

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 and before VEST implantation.
6. Prior debilitating stroke less than 1 year before surgery
7. Severe renal dysfunction (Cr>2.0 mg/dL)
8. Concomitant life-threatening disease likely to limit life expectancy to less than 2 years.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VEST	VEST	-

Primary Outcome Measures

Name	Time	Method
Vein graft patency by CT angiography	3-6 monthws
MACCE	3-6 months	Major adverse cardiac and cerebral events

Trial Locations

Locations (2)

The John Radcliffe Hospital; 🇬🇧 Oxford, United Kingdom

Krankenhaus der Barmherzigen Bruder; 🇩🇪 Trier, Germany