VIOLA Post Market Surveillance Clinical Protocol

Vascular Graft Solutions Ltd.15 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Coronary Artery Disease

Interventions

VIOLA proximal sealDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 11. Women of child bearing age 12. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.

Locations (1)

Rambam Health Care Campus

Haifa, Israel

Outcomes

Primary Outcomes

Technical success of the VIOLA device

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

Time frame: Acute, intraoperative

Secondary Outcomes

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

Time frame: Acute, intraoperative

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

Time frame: Acute, intraoperative

Data from ClinicalTrials.gov

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