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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01356888
Recruitment Status : Active, not recruiting
First Posted : May 20, 2011
Last Update Posted : May 31, 2018
Information provided by (Responsible Party):
Biotronik AG

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Percutaneous Coronary Intervention (Abbott Laboratories - Xience Prime DES) Device: Percutaneous Coronary Intervention (Orsiro DES) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 452 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: BIOTRONIK-Safety and Clinical PerFormance of the Drug ELuting Orsiro Stent in the Treatment of Subjects With Single de Novo Coronary Artery Lesions - II
Study Start Date : May 2011
Actual Primary Completion Date : July 2013
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Active Comparator: Abbott Laboratories - Xience Prime DES Device: Percutaneous Coronary Intervention (Abbott Laboratories - Xience Prime DES)

Experimental: Biotronik - Orsiro DES Device: Percutaneous Coronary Intervention (Orsiro DES)

Primary Outcome Measures :
  1. Late Lumen Loss [ Time Frame: 9 months post index procedure ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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 ≥ 2.25 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01356888

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