BIOTRONIK-Safety and Clinical PerFormance of the Drug Eluting ORSIRO Stent in the Treatment of Patients With Single de Novo Coronary Artery Lesions in an Indian Population

Biotronik AG4 sites in 1 country120 target enrollmentAugust 2011

ConditionsCoronary Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Biotronik AG
Enrollment: 120
Locations: 4
Primary Endpoint: In-Stent Late Lumen Loss
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this clinical investigation is to assess the safety and clinical performance of the Orsiro Limus Eluting Stent System in Indian subjects with single de-novo coronary artery lesions.

Registry

clinicaltrials.gov

Start Date

August 2011

End Date

February 2013

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Biotronik AG

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject has provided a written informed consent
•Single de novo lesion with ≥ 50% and \<100% stenosis in up to 2 coronary arteries
•The target lesion length is ≤ 26 mm
•The target reference vessel diameter is ≥ 2.0 mm and ≤ 4.0 mm

Exclusion Criteria

•Evidence of myocardial infarction within 72 hours prior to index procedure
•Unprotected left main coronary artery disease (stenosis \>50%)
•Three-vessel coronary artery disease at time of procedure Thrombus in target vessel
•Target lesion involves a side branch \> 2.0 mm in diameter
•Heavily calcified lesion
•Target lesion is located in or supplied by an arterial or venous bypass graft