VIOLA Post Market Surveillance Clinical Protocol

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: VIOLA proximal seal

• Registration Number: NCT05914246
• Lead Sponsor: Vascular Graft Solutions Ltd.

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.

Study Timeline

• Study First Submitted: 2023-05-28
• Study First Submitted QC: 2023-06-12
• Study First Posted: 2023-06-22
• Study Start: 2023-07-05
• Primary Completion: 2024-01-09
• Study Completion: 2024-07-16
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. Patient scheduled for isolated CABG on clinical grounds
2. One or more bypass grafts originating from the aorta
3. Ability to give their informed written consent
4. Ability and willingness to comply with study follow up requirements
5. Patient is ≥ 18 years of age

Exclusion Criteria

1. Emergency CABG surgery (cardiogenic shock, inotropic pressure support, IABP)
2. Prior clinical stroke less than one year before surgery
3. Pre-operative neurological deficits
4. Chronic atrial fibrillation
5. Aortic external diameter less than 25 mm measured intraoperatively
6. No proximal aortic anastomosis eligible for VIOLA use, assessed intraoperatively according to surgeon's discretion (E.G inadequate punch size, thin-walled aorta).
7. Symptomatic carotid disease
8. Acute MI within 24 hours of planned surgery
9. EuroScore II ≥ 4
10. Known allergy to nickel
11. Women of child bearing age
12. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CABG surgery with use of VIOLA	VIOLA proximal seal	patients will be treated for routine CABG, using VIOLA for maintaining hemostasis during suturing of multiple aortic anastomoses

Primary Outcome Measures

Name	Time	Method
Technical success of the VIOLA device	Acute, intraoperative	Proportion of proximal anastomoses that were completed without use of an aortic clamp

Secondary Outcome Measures

Name	Time	Method
Sealing quality	Acute, intraoperative	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
Ease of proximal anastomosis suturing	Acute, intraoperative	Ease of suturing will be assessed by the surgeon using a 5-point Likert scale where 1=Poor and 5=Excellent

Trial Locations

Locations (1)

Rambam Health Care Campus; 🇮🇱 Haifa, Israel