Loading clinical trials...

COMPLETEDNA

VIOLA Post Market Surveillance Clinical Protocol

VIOLA PMS Clinical Protocol

NCT05914246•Vascular Graft Solutions Ltd.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+2 more criteria

Locations (1)

Rambam Health Care Campus

Haifa, Israel

Key Dates

Start Date

July 5, 2023

Primary Completion Date

January 9, 2024

Completion Date

July 16, 2024

Last Updated

February 6, 2025

Enrollment

ACTUAL participants

Conditions

Coronary Artery Disease

Interventions

VIOLA proximal seal

DEVICE

Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI

NCT05681702

Coronary Artery Disease

View study

RECRUITING

"Erectile Function After PCI in MI and Non-MI Patients"

NCT07444697

Erectile DisfunctionCoronary Artery Disease (CAD)+3 more

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

VIOLA Post Market Surveillance Clinical Protocol

Inclusion Criteria

Exclusion Criteria

Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI

"Erectile Function After PCI in MI and Non-MI Patients"

Revascularization Strategies in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) and Severe Coronary Artery Disease

Product Surveillance Registry

Essential Pro Study ( rEPIC04E-HK )

Factors Affect Outcomes in Cardiovascular Surgery