Biomime Stent in All-comers PCI Patients Registry

• Conditions: Coronary Artery Disease

• Registration Number: NCT02398955
• Lead Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Status Verified: 2015-03
• Study First Submitted: 2015-03-22
• Study First Submitted QC: 2015-03-25
• Last Update Submitted: 2015-03-25
• Study First Posted: 2015-03-26
• Last Update Posted: 2015-03-26
• Primary Completion: 2016-06
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

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

Exclusion Criteria

• patients <18 years old

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
death from any cause	1 year	death from any cause after the procedure
target lesion revascularization	1 year	rate of target lesion percutaneous reintervention for recurrent symptoms or inducible ischemia at follow up testes

Trial Locations

Locations (1)

Azienda Ospedaliero Universitaria Maggiore della Carita; 🇮🇹 Novara, Piedmont, Italy