CD0104 VEST II Post Marketing Surveillance Study

Coronary Artery Bypass Surgery Clinical Trial

— VEST II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02332330
• Other study ID #: CD0104
• Status: Completed
• Phase: N/A
• First received: January 4, 2015
• Last updated: April 27, 2016
• Start date: January 2015
• Est. completion date: April 2016

Study information

• Verified date: October 2015
• Source: Vascular Graft Solutions Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Bypass Surgery

Intervention

Device:
• VEST

Locations

Country	Name	City	State
Germany	Krankenhaus der Barmherzigen Bruder	Trier
United Kingdom	The John Radcliffe Hospital	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
Vascular Graft Solutions Ltd.

Countries where clinical trial is conducted

Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vein graft patency by CT angiography		3-6 monthws	No
Primary	MACCE	Major adverse cardiac and cerebral events	3-6 months	Yes