BIOFLOW-INDIA Safety and Clinical PerFormance of the Drug Eluting ORSIRO Stent in Single de Novo Coronary Artery Lesions
NCT ID: NCT01426139
Last Updated: 2013-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2011-08-31
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Biotronik Orsiro DES
Percutaneous Coronary Intervention Biotronik Orsiro DES
Stenting
Interventions
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Percutaneous Coronary Intervention Biotronik Orsiro DES
Stenting
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Biotronik AG
INDUSTRY
Responsible Party
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Locations
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Madras Medical Mission
Chennai, , India
Medanta The Medicity Hospital
Gurgaon, , India
Max Super Speciality Hospital
New Delhi, , India
Fortis Escorts Heart Institute and Research Centre
New Delhi, , India
Countries
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Other Identifiers
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C1002
Identifier Type: -
Identifier Source: org_study_id
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