Coronary Artery Disease
Conditions
Keywords
CABG, Coronary artery bypass grafting
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.
Interventions
DEVICEVIOLA proximal seal
VIOLA proximal seal system for maintenance of hemostasis when suturing the aortic anastomoses
Sponsors
Vascular Graft Solutions Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical success of the VIOLA device | Acute, intraoperative | Proportion of proximal anastomoses that were completed without use of an aortic clamp |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sealing quality | 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 |
| Ease of proximal anastomosis suturing | Acute, intraoperative | Ease of suturing will be assessed by the surgeon using a 5-point Likert scale where 1=Poor and 5=Excellent |
Countries
Israel
Outcome results
None listed