VIOLA Post Market Surveillance Clinical Protocol

Study Overview
=================
Brief 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.

Official Title
-----------------
VIOLA PMS Clinical Protocol

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: VIOLA proximal seal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient scheduled for isolated CABG on clinical grounds One or more bypass grafts originating from the aorta Ability to give their informed written consent Ability and willingness to comply with study follow up requirements Patient is ≥ 18 years of age Exclusion Criteria: Emergency CABG surgery (cardiogenic shock, inotropic pressure support, IABP) Prior clinical stroke less than one year before surgery Pre-operative neurological deficits Chronic atrial fibrillation Aortic external diameter less than 25 mm measured intraoperatively No proximal aortic anastomosis eligible for VIOLA use, assessed intraoperatively according to surgeon's discretion (E.G inadequate punch size, thin-walled aorta). Symptomatic carotid disease Acute MI within 24 hours of planned surgery EuroScore II ≥ 4 Known allergy to nickel Women of child bearing age Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CABG surgery with use of VIOLA<br>patients will be treated for routine CABG, using VIOLA for maintaining hemostasis during suturing of multiple aortic anastomoses | Device: VIOLA proximal seal<br>* VIOLA proximal seal system for maintenance of hemostasis when suturing the aortic anastomoses<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success of the VIOLA device | Proportion of proximal anastomoses that were completed without use of an aortic clamp | Acute, intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sealing quality | Sealing quality will be assessed by the surgeon using a 3-point Likert scale. Sealing will be assessed as: 1) Perfect; 2)Acceptable; or 3) Unacceptable | Acute, intraoperative | 
| Ease of proximal anastomosis suturing | Ease of suturing will be assessed by the surgeon using a 5-point Likert scale where 1=Poor and 5=Excellent | Acute, intraoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CABG, Coronary artery bypass grafting