CD0104 VEST II Post Marketing Surveillance Study

Vascular Graft Solutions Ltd.30 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Coronary Artery Bypass Surgery

Interventions

VESTDEVICE

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (2)

Krankenhaus der Barmherzigen Bruder

Trier, Germany

The John Radcliffe Hospital

Oxford, United Kingdom

Outcomes

Primary Outcomes

Vein graft patency by CT angiography

Time frame: 3-6 monthws

MACCE

Major adverse cardiac and cerebral events

Time frame: 3-6 months

Data from ClinicalTrials.gov

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