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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05914246
Other study ID # CD0314
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 5, 2023
Est. completion date January 2025

Study information

Verified date February 2024
Source Vascular Graft Solutions Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 15
Est. completion date January 2025
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Israel Rambam Health Care Campus Haifa

Sponsors (1)

Lead Sponsor Collaborator
Vascular Graft Solutions Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Technical success of the VIOLA device Proportion of proximal anastomoses that were completed without use of an aortic clamp Acute, intraoperative
Secondary 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
Secondary 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 Acute, intraoperative
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