Biomime Stent in All-comers PCI Patients Registry

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02398955

Acronym

BELLINI

Enrollment

250

Registered

2015-03-26

Start date

2014-06-30

Completion date

2016-12-31

Last updated

2015-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Drug-Eluting Stents, Coronary Artery Disease, Sirolimus, Absorbable Implants

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.

Interventions

DEVICEpercutaneous coronary intervention

percutaneous coronary angioplasty with implantation of at least one Biomime stent

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* patients \<18 years old

Design outcomes

Primary

Measure	Time frame	Description
target vessel revascularization	1 year	rate of target vessel percutaneous or surgical reintervention for recurrent symptoms or inducible ischemia at follow up testes

Secondary

Measure	Time frame	Description
death from any cause	1 year	death from any cause after the procedure
cardiac death	1 year	death form cardiac causes (reinfarction, sudden cardiac death, death during coronary reintervention, heart failure, arrhythmias)
reinfarction	1 year	reinfarction in the myocardial region supplied by the treated coronary artery
target lesion revascularization	1 year	rate of target lesion percutaneous reintervention for recurrent symptoms or inducible ischemia at follow up testes

Countries

Italy

Contacts

Primary ContactAlessandro Lupi, MD

lupialessandro1@tin.it+3903213733236

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026