VIOLA Post Market Surveillance Clinical Protocol

Status Active, not recruiting

Clinical Trial Summary

The goal of this post marketing surveillance clinical trial is to learn about VIOLA as a proximal seal device in patients undergoing coronary artery grafting (CABG) surgery. The main objective is to evaluate the clinical safety and performance of the VIOLA. Participants will be treated with routine CABG with use of VIOLA for maintaining hemostasis when suturing the proximal anastomosis. Patients will be followed for any clinical events at 6 weeks and 9 months post surgery.

Clinical Trial Description

The goal of this post marketing surveillance clinical trial is to collect post market data on the safety and performance of VIOLA as a proximal seal device in patients undergoing coronary artery grafting (CABG) surgery. The main objective is to evaluate the clinical safety and performance of the VIOLA. Participants will be treated with routine CABG with use of VIOLA for maintaining hemostasis when suturing the proximal anastomosis. Data will be collected intraoperatively, at discharge, at 6 weeks, and at 9 months post CABG. ;

Study Design

Related Conditions & MeSH terms

Coronary Artery Disease

Clinical Trial Details

NCT number	NCT05914246
Study type	Interventional
Source	Vascular Graft Solutions Ltd.
Contact
Status	Active, not recruiting
Phase	N/A
Start date	July 5, 2023
Completion date	January 2025

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