- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02398955
Biomime Stent in All-comers PCI Patients Registry (BELLINI)
March 25, 2015 updated by: Lupi Alessandro, Azienda Ospedaliero Universitaria Maggiore della Carita
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
250
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Alessandro Lupi, MD
- Phone Number: +3903213733236
- Email: lupialessandro1@tin.it
Study Locations
-
-
Piedmont
-
Novara, Piedmont, Italy, 28100
- Recruiting
- Azienda Ospedaliero Universitaria Maggiore della Carita
-
Contact:
- Alessandro Lupi, M.D.
- Phone Number: +393495643838
- Email: lupialessandro1@tin.it
-
Principal Investigator:
- Alessandro Lupi, M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All comers patients with coronary artery disease treated with percutaneous coronary intervention and a Biomime stent, age > 18 years
Description
Inclusion Criteria:
- any coronary artery disease treated with percutaneous coronary intervention and a Biomime stent
Exclusion Criteria:
- patients <18 years old
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Study cohort
All comers patients with coronary artery disease treated with percutaneous coronary intervention and at least one Biomime stent
|
percutaneous coronary angioplasty with implantation of at least one Biomime stent
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
death from any cause
Time Frame: 1 year
|
death from any cause after the procedure
|
1 year
|
cardiac death
Time Frame: 1 year
|
death form cardiac causes (reinfarction, sudden cardiac death, death during coronary reintervention, heart failure, arrhythmias)
|
1 year
|
reinfarction
Time Frame: 1 year
|
reinfarction in the myocardial region supplied by the treated coronary artery
|
1 year
|
target lesion revascularization
Time Frame: 1 year
|
rate of target lesion percutaneous reintervention for recurrent symptoms or inducible ischemia at follow up testes
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Alessandro Lupi, MD, Azienda Ospedaliero Universitaria Maggiore della Carita
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2014
Primary Completion (Anticipated)
June 1, 2016
Study Completion (Anticipated)
December 1, 2016
Study Registration Dates
First Submitted
March 22, 2015
First Submitted That Met QC Criteria
March 25, 2015
First Posted (Estimate)
March 26, 2015
Study Record Updates
Last Update Posted (Estimate)
March 26, 2015
Last Update Submitted That Met QC Criteria
March 25, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BELLINI01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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