CD0104 VEST II Post Marketing Surveillance Study (VEST II)

A Post-market Prospective Study of the VGS VEST (Venous External Support), Supporting Saphenous Vein Grafts for Coronary Bypass Graft Surgery in Patients With Severe Coronary Heart Disease

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Bypass Surgery
• Intervention / Treatment: Device: VEST

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Trier, Germany
    • Krankenhaus der Barmherzigen Brüder
• United Kingdom
  • Oxford, United Kingdom
    • The John Radcliffe Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VEST	Device: VEST

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vein graft patency by CT angiography		3-6 monthws
MACCE	Major adverse cardiac and cerebral events	3-6 months

Collaborators and Investigators

• Sponsor: Vascular Graft Solutions Ltd.
• Investigators: Principal Investigator: David P Taggart, Professor, Oxford University Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: January 4, 2015
• First Submitted That Met QC Criteria: January 4, 2015
• First Posted (Estimate): January 6, 2015

Study Record Updates

• Last Update Posted (Estimate): April 28, 2016
• Last Update Submitted That Met QC Criteria: April 27, 2016
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: CD0104