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 Locations

  • Italy
    • Piedmont
      • Novara, Piedmont, Italy, 28100
        • Recruiting
        • Azienda Ospedaliero Universitaria Maggiore della Carità
        • Contact:
        • 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
Device: percutaneous coronary intervention
percutaneous coronary angioplasty with implantation of at least one Biomime stent
Other Names:
  • Biomime stent

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.

Sponsor

Azienda Ospedaliero Universitaria Maggiore della Carita

Investigators

  • Principal Investigator: Alessandro Lupi, MD, Azienda Ospedaliero Universitaria Maggiore della Carità

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

Keywords

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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