VIOLA Post Market Surveillance Clinical Protocol

NCT05914246 | Completed

• 1 other identifier: CD0314
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

CABG; Coronary artery bypass grafting

Outcome Measures

Primary Outcomes (1)

• Technical success of the VIOLA device

  Proportion of proximal anastomoses that were completed without use of an aortic clamp

  Acute, intraoperative

Secondary Outcomes (2)

• Sealing quality

  Acute, intraoperative

• Ease of proximal anastomosis suturing

  Acute, intraoperative

Study Arms (1)

CABG surgery with use of VIOLA

EXPERIMENTAL

patients will be treated for routine CABG, using VIOLA for maintaining hemostasis during suturing of multiple aortic anastomoses

Device: VIOLA proximal seal

Interventions

VIOLA proximal seal DEVICE

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

CABG surgery with use of VIOLA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vascular Graft Solutions Ltd.: lead

Study Sites (1)

Rambam Health Care Campus

Haifa, 31096, Israel

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Gil Bolotin, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2023
• First Posted: June 22, 2023
• Study Start: July 5, 2023
• Primary Completion: January 9, 2024
• Study Completion: July 16, 2024
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)