Coronary Artery DiseaseNCT05914246
VIOLA Post Market Surveillance Clinical Protocol
A study testing VIOLA proximal seal in people with Coronary Artery Disease, run by Vascular Graft Solutions Ltd. at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- VIOLA proximal seal
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- 5 Jul 2023to 16 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Emergency CABG surgery (cardiogenic shock, inotropic pressure support, IABP)
- Prior clinical stroke less than one year before surgery
- 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).
Show all 12Show fewer
- Symptomatic carotid disease
- Acute MI within 24 hours of planned surgery
- EuroScore II ≥ 4
- Known allergy to nickel
- Women of child bearing age
- Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: VIOLA PMS Clinical Protocol
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- VIOLA proximal seal
- Keywords
- CABG, Coronary artery bypass grafting
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIOLA proximal sealDevice
VIOLA proximal seal system for maintenance of hemostasis when suturing the aortic anastomoses
| Study group | Role | What they receive |
|---|---|---|
| CABG surgery with use of VIOLA | Experimental | patients will be treated for routine CABG, using VIOLA for maintaining hemostasis during suturing of multiple aortic anastomoses Receives: Device: VIOLA proximal seal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success of the VIOLA device
Proportion of proximal anastomoses that were completed without use of an aortic clamp
Measured: Acute, intraoperative
Secondary outcomes (2)
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
Measured: 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
Measured: Acute, intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start5 Jul 2023
- Primary completion9 Jan 2024
- Study completion16 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vascular Graft Solutions Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gil Bolotin, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05914246
- Sponsor's protocol ID
- CD0314
- Status last verified
- Feb 2025
- First submitted
- 28 May 2023
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIOLA PMS Clinical Protocol
- ClinicalTrials.gov ID
- NCT05914246
- Acronym / sponsor ID
- CD0314
- Conditions
- Coronary Artery Disease
- Keywords
- CABG, Coronary artery bypass grafting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Vascular Graft Solutions Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 9 Jan 2024 (actual)
- Study completion
- 16 Jul 2024 (actual)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CABG surgery with use of VIOLA | Experimental | Device: VIOLA proximal sealpatients will be treated for routine CABG, using VIOLA for maintaining hemostasis during suturing of multiple aortic anastomoses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- Emergency CABG surgery (cardiogenic shock, inotropic pressure support, IABP)
- Prior clinical stroke less than one year before surgery
- Pre-operative neurological deficits
- Chronic atrial fibrillation
- Aortic external diameter less than 25 mm measured intraoperatively
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIOLA proximal sealVIOLA proximal seal system for maintenance of hemostasis when suturing the aortic anastomoses | Device | CABG surgery with use of VIOLA |
Primary outcome
Technical success of the VIOLA device
Time frame: Acute, intraoperative
Proportion of proximal anastomoses that were completed without use of an aortic clamp
2 secondary outcomes
Sealing quality
Time frame: Acute, intraoperative
Ease of proximal anastomosis suturing
Time frame: Acute, intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Disease
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
RecruitingPhase 4
CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes Patients With Stage 4 CKM Syndrome
ACS (Acute Coronary Syndrome), SGLT2 Inhibitors
Not yet recruiting
Effect of Propionic Acid Supplementation on Endothelial Function
Cardiovascular Diseases, Endothelial Dysfunction
Recruiting
Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With Stable Angina or ACS - A Traditional Feasibility Study
Coronary Arterial Disease (CAD), Plaque
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gil Bolotin, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIOLA proximal seal in people with Coronary Artery Disease, run by Vascular Graft Solutions Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success of the VIOLA device (time frame: Acute, intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.