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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biotronik AG
ClinicalTrials.gov Identifier:
NCT01426139
First received: August 10, 2011
Last updated: April 3, 2013
Last verified: April 2013
  Purpose

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
Endpoint Classification: Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Biotronik AG:

Primary Outcome Measures:
  • In-Stent Late Lumen Loss [ Time Frame: 9 months post index procedure ] [ Designated as safety issue: No ]

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
Stenting

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01426139

Locations
India
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

No publications provided

Responsible Party: Biotronik AG
ClinicalTrials.gov Identifier: NCT01426139     History of Changes
Other Study ID Numbers: C1002
Study First Received: August 10, 2011
Last Updated: April 3, 2013
Health Authority: India: Drugs Controller General of India

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014