Biomime Stent in All-comers PCI Patients Registry

• Conditions: Coronary Artery Disease
• Interventions: Device: percutaneous coronary intervention

• 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

Arm && Interventions

Group	Intervention	Description
Study cohort	percutaneous coronary intervention	All comers patients with coronary artery disease treated with percutaneous coronary intervention and at least one Biomime stent

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
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

Trial Locations

Locations (1)

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