VIOLA Post Market Surveillance Clinical Protocol

Coronary Artery Disease Clinical Trial

Official title:

VIOLA PMS Clinical Protocol

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05914246
• Other study ID #: CD0314
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 5, 2023
• Est. completion date: January 2025

Study information

• Verified date: February 2024
• Source: Vascular Graft Solutions Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 15
• Est. completion date: January 2025
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• VIOLA proximal seal
VIOLA proximal seal system for maintenance of hemostasis when suturing the aortic anastomoses

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Vascular Graft Solutions Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical success of the VIOLA device	Proportion of proximal anastomoses that were completed without use of an aortic clamp	Acute, intraoperative
Secondary	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
Secondary	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