Coronary Artery DiseaseVIBERNCT01411462
VIBE-assisted DEB Registry
An observational study of Coronary Artery Disease, run by Ospedale Santa Maria Goretti at 1 site in Italy.
Trial summary
VIBER aims at assessing angiographic outcome of drug-eluting balloon angioplasty assisted by the Vascular Imaging Balloon Catheter (VIBE, Volcano, San Diego, CA) device, which integrates a predilation catheter with electronic intravascular ultrasound capabilities. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- VIBE + drug-eluting balloon
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- Aug 2011to Jan 2012
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with symptomatic coronary artery disease
Who may be able to join
- Age >18 years
- De novo native vessel lesion
- RVD 2.5 - 4 mm Limited compliance with >3 month DAPT
Who cannot join
- LMCA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vascular Imaging Balloon Catheter-assisted Drug-eluting Balloon Angioplasty Prospective Registry
VIBER aims at assessing angiographic outcome of drug-eluting balloon angioplasty assisted by the Vascular Imaging Balloon Catheter (VIBE, Volcano, San Diego, CA) device, which integrates a predilation catheter with electronic intravascular ultrasound capabilities.
- Conditions
- Coronary Artery Disease
- Being tested
- VIBE + drug-eluting balloon
- 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.
VIBE + drug-eluting balloonDevice
VIBE before and after durg-eluting balloon angioplasty
| Study group | Role | What they receive |
|---|---|---|
| VIBE-DEB | Not described Receives: Device: VIBE + drug-eluting balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binary restenosis
Number of patients with a diameter stenosis >50% assessed by quantitative coronary angiography
Measured: 6 months
Secondary outcomes (2)
Procedural success
Number of patients with both post-procedure diameter stenosis <20% assessed by quantitative coronary angiography and TIMI 3 flow
Measured: 1 day
Major adverse cardiac events
Number of patients with one of the following events: cardiac death, non-fatal myocardial infarction, target lesion revascularization
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2011 (estimated)
- Study startAug 2011 (estimated)
- Primary completionOct 2011 (estimated)
- Study completionJan 2012
Why it stopped: Funding issues
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Santa Maria Goretti
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregory Sgueglia, MD, Ospedale Santa Maria Goretti
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01411462
- Sponsor's protocol ID
- SMG-007
- Acronym
- VIBER
- Status last verified
- Feb 2020
- First submitted
- 3 Aug 2011
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Imaging Balloon Catheter-assisted Drug-eluting Balloon Angioplasty Prospective Registry
- ClinicalTrials.gov ID
- NCT01411462
- Acronym / sponsor ID
- VIBER / SMG-007
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Funding issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ospedale Santa Maria GorettiUniversity, hospital or other
- Study start
- Aug 2011 (estimated)
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Jan 2012 (actual)
- First posted
- 8 Aug 2011 (estimated)
- 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.
VIBER aims at assessing angiographic outcome of drug-eluting balloon angioplasty assisted by the Vascular Imaging Balloon Catheter (VIBE, Volcano, San Diego, CA) device, which integrates a predilation catheter with electronic intravascular ultrasound capabilities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VIBE-DEB | – | Device: VIBE + drug-eluting balloon |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptomatic coronary artery disease
Key inclusion criteria (3 listed)
- Age >18 years
- De novo native vessel lesion
- RVD 2.5 - 4 mm Limited compliance with >3 month DAPT
Key exclusion criteria (1 listed)
- LMCA
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 |
|---|---|---|
| VIBE + drug-eluting balloonVIBE before and after durg-eluting balloon angioplasty | Device | VIBE-DEB |
Primary outcome
Binary restenosis
Time frame: 6 months
Number of patients with a diameter stenosis >50% assessed by quantitative coronary angiography
2 secondary outcomes
Procedural success
Time frame: 1 day
Major adverse cardiac events
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Ospedale Santa Maria Goretti at 1 site in Italy.
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 3 inclusion and 1 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: withdrawn, as of the sponsor's last update on 25 Feb 2020. 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 Italy. 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 was withdrawn before enrolling participants, so there are no results.
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?
Binary restenosis (time frame: 6 months). 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 25 Feb 2020.