VIOLA Post Market Surveillance Clinical Protocol | NCT05914246

Studies
VIOLA Post Market Surveillance Clinical Protocol

NCT05914246

Sponsor

Vascular Graft Solutions Ltd.

Status

Completed

Last Update Posted

Feb 6, 2025Actual

Enrollment

15Actual

Phase

Not Applicable

Conditions

Coronary Artery Disease

Interventions

VIOLA proximal seal

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 5, 2023Actual

Primary Completion Date

Jan 9, 2024Actual

Completion Date

Jul 16, 2024Actual

First Submitted Date

May 28, 2023

First Submission Date that Met QC Criteria

Jun 12, 2023

First Posted Date

Jun 22, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2025

Last Update Posted Date

Feb 6, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
VIOLA proximal seal	Device	VIOLA proximal seal system for maintenance of hemostasis when suturing the aortic anastomoses	CABG surgery with use of VIOLA

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Gil Bolotin, MD	Rambam Health Care Campus	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Rambam Health Care Campus		Haifa		31096	Israel

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

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Browse Branches

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