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

April 3, 2013 updated by: Biotronik AG

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Chennai, India, 600037
        • Madras Medical Mission
      • Gurgaon, India, 122001
        • Medanta the medicity hospital
      • New Delhi, India, 110017
        • Max Super Speciality Hospital
      • New Delhi, India, 110025
        • Fortis Escorts Heart Institute and Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biotronik Orsiro DES
Device: Percutaneous Coronary Intervention Biotronik Orsiro DES
Stenting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
In-Stent Late Lumen Loss
Time Frame: 9 months post index procedure
9 months post index procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotronik AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

August 10, 2011

First Submitted That Met QC Criteria

August 30, 2011

First Posted (Estimate)

August 31, 2011

Study Record Updates

Last Update Posted (Estimate)

April 4, 2013

Last Update Submitted That Met QC Criteria

April 3, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C1002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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