VIOLA Post Market Surveillance Clinical Protocol

Vascular Graft Solutions

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: VIOLA proximal seal

Study type: Interventional

Funder types: Industry

Identifiers

NCT05914246

CD0314

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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
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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

CABG surgery with use of VIOLA

Experimental group

Description:

patients will be treated for routine CABG, using VIOLA for maintaining hemostasis during suturing of multiple aortic anastomoses

Treatment:

Device: VIOLA proximal seal