VIOLA Post Market Surveillance Clinical Protocol
February 3, 2025 updated by: Vascular Graft Solutions Ltd.
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
Completed
Conditions
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Haifa, Israel, 31096
- Rambam Health Care Campus
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
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
|
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
Time Frame: Acute, intraoperative
|
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
Time Frame: 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
|
Acute, intraoperative
|
|
Ease of proximal anastomosis suturing
Time Frame: Acute, intraoperative
|
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
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gil Bolotin, MD, Rambam Health Care Campus
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 5, 2023
Primary Completion (Actual)
January 9, 2024
Study Completion (Actual)
July 16, 2024
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)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 3, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.