NCT05914246

VIOLA Post Market Surveillance Clinical Protocol

VIOLA PMS Clinical Protocol

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Vascular Graft Solutions Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	VIOLA proximal seal	VIOLA proximal seal system for maintenance of hemostasis when suturing the aortic anastomoses

Timeline

• Start date: 2023-07-05
• Primary completion: 2024-01-09
• Completion: 2024-07-16
• First posted: 2023-06-22
• Last updated: 2025-02-06

Locations

1 site across 1 country: Israel