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

This study has been completed.
Information provided by (Responsible Party):
Biotronik AG Identifier:
First received: August 10, 2011
Last updated: April 3, 2013
Last verified: April 2013
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.

Condition Intervention
Coronary Artery Disease
Device: Percutaneous Coronary Intervention Biotronik Orsiro DES

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: BIOTRONIK-Safety and Clinical PerFormance of the Drug Eluting ORSIRO Stent in the Treatment of Patients With Single de Novo Coronary Artery Lesions in an Indian Population

Further study details as provided by Biotronik AG:

Primary Outcome Measures:
  • In-Stent Late Lumen Loss [ Time Frame: 9 months post index procedure ]

Enrollment: 120
Study Start Date: August 2011
Study Completion Date: February 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Biotronik Orsiro DES Device: Percutaneous Coronary Intervention Biotronik Orsiro DES


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01426139

Madras Medical Mission
Chennai, India, 600037
Medanta The Medicity Hospital
Gurgaon, India, 122001
Max Super Speciality Hospital
New Delhi, India, 110017
Fortis Escorts Heart Institute and Research Centre
New Delhi, India, 110025
Sponsors and Collaborators
Biotronik AG
  More Information

Responsible Party: Biotronik AG Identifier: NCT01426139     History of Changes
Other Study ID Numbers: C1002
Study First Received: August 10, 2011
Last Updated: April 3, 2013

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases processed this record on April 26, 2017