Study of the Orsiro Drug Eluting Stent System (BIOFLOW-II)

May 30, 2018 updated by: Biotronik AG

BIOTRONIK-Safety and Clinical PerFormance of the Drug ELuting Orsiro Stent in the Treatment of Subjects With Single de Novo Coronary Artery Lesions - II

The purpose of this study is to compare the BIOTRONIK Orsiro Drug Eluting Stent System with the Abbott Xience Prime™ Drug Eluting Stent System with respect to in-stent Late Lumen Loss in a non-inferiority study in de novo coronary lesions at 9 months.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

452

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

  • Austria
    • Oberoesterreich
      • Wels, Oberoesterreich, Austria, 4600
        • Klinikum Wels-Grieskirchen
  • France
      • Massy, France, 91300
        • Hospital Prive Jacques Cartier Massy
      • Montpellier, France, 34295
        • CHU - Hospital Arnaud de Villeneuve
      • Ollioules, France, 83192
        • Polyclinique les Fleurs Ollioules
  • Germany
      • Bad Krozingen, Germany, 79189
        • Heart Centre Bad Krozingen
      • Bad Oeyenhausen, Germany, 32545
        • Heart- and Diabetescentre NRW
      • Bad Segeberg, Germany, 23795
        • Segeberger Kliniken Gmbh
      • Berlin, Germany, 10117
        • Charité Campus Mitte
      • Berlin, Germany, 12203
        • Charite Campus Benjamin Franklin
      • Lübeck, Germany, 23538
        • Universityhospital Lübeck
      • Neuss, Germany, 41464
        • Städtische Kliniken Neuss, Lukaskrankenhaus GmbH
      • Nuernberg, Germany, 90471
        • Klinikum Nuernberg Sued
      • Rostock, Germany, 18057
        • Universityhospital Rostock
  • Hungary
      • Budapest, Hungary, 1122
        • Heart centre Semmelweis University
  • Latvia
      • Riga, Latvia, 1002
        • Pauls Stradins Clinical University Hospital
  • Netherlands
      • Amsterdam, Netherlands, 1091
        • OLVG (Onze Lieve Vrouwe Gasthuis)
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clínico y Provincial de Barcelona
      • Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro de Majadahonda
      • Sevilla, Spain, 41007
        • Hospital Universitario Virgen De La Macarena
  • Switzerland
      • Bern, Switzerland, 3010
        • University Hospital of Bern (Inselspital)
      • Fribourg, Switzerland, 1708
        • University Hospital of Fribourg
      • Geneva, Switzerland, 1211
        • University Hospital of Geneva
      • Lucerne, Switzerland, 6000
        • Cantone Hospital of Lucerne
    • Tessin
      • Lugano, Tessin, Switzerland, 6900
        • Cardiocentro Ticino

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

16 years to 78 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 ≥ 2.25 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Abbott Laboratories - Xience Prime DES
Device: Percutaneous Coronary Intervention (Abbott Laboratories - Xience Prime DES)
Stenting
Experimental: Biotronik - Orsiro DES
Device: Percutaneous Coronary Intervention (Orsiro DES)
stenting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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

Investigators

  • Principal Investigator: Stephan Windecker, MD, University Hospital (Inselspital) / Bern / Switzerland
  • Principal Investigator: Thierry Lefèvre, MD, Institute Hospitalier Jaques Cartier / Massy / France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2011

Primary Completion (Actual)

July 1, 2013

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

May 18, 2011

First Submitted That Met QC Criteria

May 19, 2011

First Posted (Estimate)

May 20, 2011

Study Record Updates

Last Update Posted (Actual)

May 31, 2018

Last Update Submitted That Met QC Criteria

May 30, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C1004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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