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Clinical Trials/NCT02398955
NCT02398955
Unknown
N/A

Biomime Biosorbable Polymer Sirolimus-ELuting Stent in alL-comers patIeNts Treated With Percutaneous Coronary Interventions: the BELLINI Registry

Azienda Ospedaliero Universitaria Maggiore della Carita1 site in 1 country250 target enrollmentJune 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
Azienda Ospedaliero Universitaria Maggiore della Carita
Enrollment
250
Locations
1
Primary Endpoint
target vessel revascularization
Last Updated
11 years ago

Overview

Brief 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. 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.

Registry
clinicaltrials.gov
Start Date
June 2014
End Date
December 2016
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Azienda Ospedaliero Universitaria Maggiore della Carita
Responsible Party
Principal Investigator
Principal Investigator

Lupi Alessandro

Dr Alessandro Lupi

Azienda Ospedaliero Universitaria Maggiore della Carita

Eligibility Criteria

Inclusion Criteria

  • any coronary artery disease treated with percutaneous coronary intervention and a Biomime stent

Exclusion Criteria

  • patients \<18 years old

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • cardiac death(1 year)
  • reinfarction(1 year)
  • death from any cause(1 year)
  • target lesion revascularization(1 year)

Study Sites (1)

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