BIOFLOW-INDIA Safety and Clinical PerFormance of the Drug Eluting ORSIRO Stent in Single de Novo Coronary Artery Lesions

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01426139

Enrollment

120

Registered

2011-08-31

Start date

2011-08-31

Completion date

2013-02-28

Last updated

2013-04-04

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

Conditions

Coronary Artery Disease

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.

Interventions

DEVICEPercutaneous Coronary Intervention Biotronik Orsiro DES

Stenting

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

Main 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 Main

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

Design outcomes

Primary

Measure	Time frame
In-Stent Late Lumen Loss	9 months post index procedure

Countries

India

Outcome results

None listed

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