CD0104 VEST II Post Marketing Surveillance Study

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02332330

Acronym

VEST II

Enrollment

Registered

2015-01-06

Start date

2015-01-31

Completion date

2016-04-30

Last updated

2016-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Bypass Surgery

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.

Interventions

DEVICEVEST

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Germany, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026