Status:
COMPLETED
BIOFLOW-INDIA Safety and Clinical PerFormance of the Drug Eluting ORSIRO Stent in Single de Novo Coronary Artery Lesions
Lead Sponsor:
Biotronik AG
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- Main
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01426139
Start Date
August 1 2011
End Date
February 1 2013
Last Update
April 4 2013
Active Locations (4)
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1
Madras Medical Mission
Chennai, India, 600037
2
Medanta The Medicity Hospital
Gurgaon, India, 122001
3
Max Super Speciality Hospital
New Delhi, India, 110017
4
Fortis Escorts Heart Institute and Research Centre
New Delhi, India, 110025