Back to resultsVIOLA Post Market Surveillance Clinical Protocol
Primary Purpose
Coronary Artery Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
VIOLA proximal seal
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring CABG, Coronary artery bypass grafting
Eligibility Criteria
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.
Sites / Locations
- Rambam Health Care Campus
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CABG surgery with use of VIOLA
Arm Description
patients will be treated for routine CABG, using VIOLA for maintaining hemostasis during suturing of multiple aortic anastomoses
Outcomes
Primary Outcome Measures
Technical success of the VIOLA device
Proportion of proximal anastomoses that were completed without use of an aortic clamp
Secondary Outcome Measures
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
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
Full Information
NCT ID
NCT05914246
First Posted
May 28, 2023
Last Updated
June 12, 2023
Sponsor
Vascular Graft Solutions Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05914246
Brief Title
VIOLA Post Market Surveillance Clinical Protocol
Official Title
VIOLA PMS Clinical Protocol
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vascular Graft Solutions Ltd.
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
CABG, Coronary artery bypass grafting
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CABG surgery with use of VIOLA
Arm Type
Experimental
Arm Description
patients will be treated for routine CABG, using VIOLA for maintaining hemostasis during suturing of multiple aortic anastomoses
Intervention Type
Device
Intervention Name(s)
VIOLA proximal seal
Intervention Description
VIOLA proximal seal system for maintenance of hemostasis when suturing the aortic anastomoses
Primary Outcome Measure Information:
Title
Technical success of the VIOLA device
Description
Proportion of proximal anastomoses that were completed without use of an aortic clamp
Time Frame
Acute, intraoperative
Secondary Outcome Measure Information:
Title
Sealing quality
Description
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
Time Frame
Acute, intraoperative
Title
Ease of proximal anastomosis suturing
Description
Ease of suturing will be assessed by the surgeon using a 5-point Likert scale where 1=Poor and 5=Excellent
Time Frame
Acute, intraoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Neta Peleg
Phone
+97235499054
Email
neta@graftsolutions.com
First Name & Middle Initial & Last Name or Official Title & Degree
Orit Yarden
Phone
+97235499054
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gil Bolotin, MD
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gal Gidron
Phone
+972 (4) 777- 2048
Email
G_GIDRON@rambam.health.gov.il
First Name & Middle Initial & Last Name & Degree
Gil Bolotin, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
VIOLA Post Market Surveillance Clinical Protocol
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