Back to resultsBIOFLOW-INDIA Safety and Clinical PerFormance of the Drug Eluting ORSIRO Stent in Single de Novo Coronary Artery Lesions
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Percutaneous Coronary Intervention Biotronik Orsiro DES
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility 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
Sites / Locations
- Madras Medical Mission
- Medanta The Medicity Hospital
- Max Super Speciality Hospital
- Fortis Escorts Heart Institute and Research Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Biotronik Orsiro DES
Arm Description
Outcomes
Primary Outcome Measures
In-Stent Late Lumen Loss
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01426139
Brief Title
BIOFLOW-INDIA Safety and Clinical PerFormance of the Drug Eluting ORSIRO Stent in Single de Novo Coronary Artery Lesions
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotronik AG
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biotronik Orsiro DES
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Percutaneous Coronary Intervention Biotronik Orsiro DES
Intervention Description
Stenting
Primary Outcome Measure Information:
Title
In-Stent Late Lumen Loss
Time Frame
9 months post index procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Madras Medical Mission
City
Chennai
ZIP/Postal Code
600037
Country
India
Facility Name
Medanta The Medicity Hospital
City
Gurgaon
ZIP/Postal Code
122001
Country
India
Facility Name
Max Super Speciality Hospital
City
New Delhi
ZIP/Postal Code
110017
Country
India
Facility Name
Fortis Escorts Heart Institute and Research Centre
City
New Delhi
ZIP/Postal Code
110025
Country
India
12. IPD Sharing Statement
Learn more about this trial
BIOFLOW-INDIA Safety and Clinical PerFormance of the Drug Eluting ORSIRO Stent in Single de Novo Coronary Artery Lesions
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