BIOFLOW-INDIA Safety and Clinical PerFormance of the Drug Eluting ORSIRO Stent in Single de Novo Coronary Artery Lesions
NCT01426139 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2013-04-04
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.
Conditions
Interventions
- DEVICE
-
Percutaneous Coronary Intervention Biotronik Orsiro DES
Stenting
Sponsors & Collaborators
-
Biotronik AG
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-08-31
- Primary Completion
- 2012-11-30
- Completion
- 2013-02-28
Countries
- India
Study Locations
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