BIOFLOW-INDIA Safety and Clinical PerFormance of the Drug Eluting ORSIRO Stent in Single de Novo Coronary Artery Lesions
Not Applicable
Completed
- Conditions
- Coronary Artery Disease
- Interventions
- Device: Percutaneous Coronary Intervention Biotronik Orsiro DES
- Registration Number
- NCT01426139
- Lead Sponsor
- Biotronik AG
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Biotronik Orsiro DES Percutaneous Coronary Intervention Biotronik Orsiro DES -
- Primary Outcome Measures
Name Time Method In-Stent Late Lumen Loss 9 months post index procedure
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Medanta The Medicity Hospital
🇮🇳Gurgaon, India
Madras Medical Mission
🇮🇳Chennai, India
Max Super Speciality Hospital
🇮🇳New Delhi, India
Fortis Escorts Heart Institute and Research Centre
🇮🇳New Delhi, India