Coronary Artery DiseaseBELLININCT02398955
Biomime Stent in All-comers PCI Patients Registry
An observational study of Coronary Artery Disease, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
Trial summary
Biomime stent is a novel sirolimus-eluting stent (SES) (Meril Life Sciences Pvt. Ltd., Gujarat, India) with an ultra-thin stent platform (65 μm) and a biodegradable polymer licensed for the treatment of de novo coronary lesions. 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?
- percutaneous coronary intervention
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2014to Dec 2016
- How long will I take part?
- 1 Year
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All comers patients with coronary artery disease treated with percutaneous coronary intervention and a Biomime stent, age > 18 years
Who may be able to join
- any coronary artery disease treated with percutaneous coronary intervention and a Biomime stent
Who cannot join
- patients <18 years old
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliero Universitaria Maggiore della Carita
Novara, Piedmont, 28100
Alessandro Lupi, M.D., +393495643838, lupialessandro1@tin.it
Alessandro Lupi, M.D.
About this study
Official title: Biomime Biosorbable Polymer Sirolimus-ELuting Stent in alL-comers patIeNts Treated With Percutaneous Coronary Interventions: the BELLINI Registry
Biomime stent is a novel sirolimus-eluting stent (SES) (Meril Life Sciences Pvt. Ltd., Gujarat, India) with an ultra-thin stent platform (65 μm) and a biodegradable polymer licensed for the treatment of de novo coronary lesions. However no data regarding the efficacy and safety of this stent in an "all-comers" patient population treated with percutaneus coronary interventions (PCI) have been published so far. In this registry the investigators aimed to collect clinical and angiographic information about an extensive "all-comers" employ of this novel stent.
- Conditions
- Coronary Artery Disease
- Being tested
- percutaneous coronary intervention
- Keywords
- Drug-Eluting Stents, Coronary Artery Disease, Sirolimus, Absorbable Implants
- 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.
percutaneous coronary interventionDevice
Also called Biomime stent
percutaneous coronary angioplasty with implantation of at least one Biomime stent
| Study group | Role | What they receive |
|---|---|---|
| Study cohort | All comers patients with coronary artery disease treated with percutaneous coronary intervention and at least one Biomime stent Receives: Device: percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
target vessel revascularization
rate of target vessel percutaneous or surgical reintervention for recurrent symptoms or inducible ischemia at follow up testes
Measured: 1 year
Secondary outcomes (4)
death from any cause
death from any cause after the procedure
Measured: 1 year
cardiac death
death form cardiac causes (reinfarction, sudden cardiac death, death during coronary reintervention, heart failure, arrhythmias)
Measured: 1 year
reinfarction
reinfarction in the myocardial region supplied by the treated coronary artery
Measured: 1 year
target lesion revascularization
rate of target lesion percutaneous reintervention for recurrent symptoms or inducible ischemia at follow up testes
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startJun 2014
- Primary completionJun 2016 (estimated)
- Study completionDec 2016 (estimated)
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lupi Alessandro, Azienda Ospedaliero Universitaria Maggiore della Carita
- Investigators
- Alessandro Lupi, MD, Principal investigator, Azienda Ospedaliero Universitaria Maggiore della Carita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02398955
- Sponsor's protocol ID
- BELLINI01
- Acronym
- BELLINI
- Status last verified
- Mar 2015
- First submitted
- 22 Mar 2015
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomime Biosorbable Polymer Sirolimus-ELuting Stent in alL-comers patIeNts Treated With Percutaneous Coronary Interventions: the BELLINI Registry
- ClinicalTrials.gov ID
- NCT02398955
- Acronym / sponsor ID
- BELLINI / BELLINI01
- Conditions
- Coronary Artery Disease
- Keywords
- Drug-Eluting Stents, Coronary Artery Disease, Sirolimus, Absorbable Implants
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della CaritaUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 26 Mar 2015 (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.
Biomime stent is a novel sirolimus-eluting stent (SES) (Meril Life Sciences Pvt. Ltd., Gujarat, India) with an ultra-thin stent platform (65 μm) and a biodegradable polymer licensed for the treatment of de novo coronary lesions. However no data regarding the efficacy and safety of this stent in an "all-comers" patient population treated with percutaneus coronary interventions (PCI) have been published so far. In this registry the investigators aimed to collect clinical and angiographic information about an extensive "all-comers" employ of this novel stent.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study cohort | – | Device: percutaneous coronary interventionAll comers patients with coronary artery disease treated with percutaneous coronary intervention and at least one Biomime stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All comers patients with coronary artery disease treated with percutaneous coronary intervention and a Biomime stent, age > 18 years
Key inclusion criteria (1 listed)
- any coronary artery disease treated with percutaneous coronary intervention and a Biomime stent
Key exclusion criteria (1 listed)
- patients <18 years old
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 |
|---|---|---|
| percutaneous coronary interventionAlso: Biomime stentpercutaneous coronary angioplasty with implantation of at least one Biomime stent | Device | Study cohort |
Primary outcome
target vessel revascularization
Time frame: 1 year
rate of target vessel percutaneous or surgical reintervention for recurrent symptoms or inducible ischemia at follow up testes
4 secondary outcomes
death from any cause
Time frame: 1 year
cardiac death
Time frame: 1 year
reinfarction
Time frame: 1 year
target lesion revascularization
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2015.
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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.
Alessandro Lupi, MD principal investigator
Azienda Ospedaliero Universitaria Maggiore della Carita
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 Azienda Ospedaliero Universitaria Maggiore della Carita 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 1 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: status not confirmed, as of the sponsor's last update on 26 Mar 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alessandro Lupi, MD (+3903213733236, lupialessandro1@tin.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
target vessel revascularization (time frame: 1 year). 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 26 Mar 2015.