NCT05914246Completed
VIOLA Post Market Surveillance Clinical Protocol
VIOLA PMS Clinical Protocol
Source: ClinicalTrials.gov · Last updated 6 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 28 May 2023
- Start date
- 5 Jul 2023
- Primary completion date
- 9 Jan 2024
- Lead sponsor
- Vascular Graft Solutions Ltd.
- Diseases
- Coronary artery disease
- NCT number
- NCT05914246
What you commit to
- Study type: Interventional
- Participants enrolled: 15
- From 5 Jul 2023 to the primary completion date, 9 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Emergency CABG surgery (cardiogenic shock, inotropic pressure support, IABP)
- Prior clinical stroke less than one year before surgery
- Acute MI within 24 hours of planned surgery
- Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.
Other illness
- Symptomatic carotid disease
- Known allergy to nickel
Age
- Women of child bearing age
Other
- 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).
- EuroScore II ≥ 4
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rambam Health Care Campus Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.