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

Biotronik

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: Percutaneous Coronary Intervention Biotronik Orsiro DES

Study type: Interventional

Funder types: Industry

Identifiers

NCT01426139

C1002

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Biotronik Orsiro DES

Experimental group

Treatment:

Device: Percutaneous Coronary Intervention Biotronik Orsiro DES