CD0104 VEST II Post Marketing Surveillance Study

Vascular Graft Solutions

Status: Completed

Conditions: Coronary Artery Bypass Surgery

Treatments: Device: VEST

Study type: Interventional

Funder types: Industry

Identifiers

NCT02332330

CD0104

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

VEST

Experimental group

Treatment:

Device: VEST