Biomime Stent in All-comers PCI Patients Registry

Coronary Artery Disease Clinical Trial

— BELLINI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02398955
• Other study ID #: BELLINI01
• Status: Recruiting
• Phase: N/A
• First received: March 22, 2015
• Last updated: March 25, 2015
• Start date: June 2014
• Est. completion date: December 2016

Study information

• Verified date: March 2015
• Source: Azienda Ospedaliero Universitaria Maggiore della Carita
• Contact: Alessandro Lupi, MD
• Phone: +3903213733236
• Email: lupialessandro1[@]tin.it
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• patients <18 years old

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• percutaneous coronary intervention
percutaneous coronary angioplasty with implantation of at least one Biomime stent

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero Universitaria Maggiore della Carita	Novara	Piedmont

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero Universitaria Maggiore della Carita

Country where clinical trial is conducted

Italy, 

Outcome

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