VIOLA Post Market Surveillance Clinical Protocol

VIOLA PMS Clinical Protocol

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: VIOLA proximal seal

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Neta Peleg; Phone Number: +97235499054; Email: neta@graftsolutions.com
• Study Contact Backup: Name: Orit Yarden; Phone Number: +97235499054

Study Locations

• Israel
  • Haifa, Israel, 31096
    • Rambam Health Care Campus
    • Contact: Gal Gidron; Phone Number: +972 (4) 777- 2048; Email: G_GIDRON@rambam.health.gov.il
    • Principal Investigator: Gil Bolotin, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Vascular Graft Solutions Ltd.
• Investigators: Principal Investigator: Gil Bolotin, MD, Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: May 28, 2023
• First Submitted That Met QC Criteria: June 12, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: CABG; Coronary artery bypass grafting
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: CD0314

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No