Trial record 2 of 15 for:    bioflow biotronik

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biotronik AG
ClinicalTrials.gov Identifier:
NCT01356888
First received: May 18, 2011
Last updated: August 8, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Coronary Artery Disease
Device: Percutaneous Coronary Intervention (Abbott Laboratories - Xience Prime DES)
Device: Percutaneous Coronary Intervention (Orsiro DES)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Biotronik AG:

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

Estimated Enrollment: 440
Study Start Date: May 2011
Estimated Study Completion Date: April 2017
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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 ≥ 2.25 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01356888

Locations
Austria
Klinikum Wels-Grieskirchen
Wels, Oberoesterreich, Austria, 4600
France
Hospital Prive Jacques Cartier Massy
Massy, France, 91300
CHU - Hospital Arnaud de Villeneuve
Montpellier, France, 34295
Polyclinique les Fleurs Ollioules
Ollioules, France, 83192
Germany
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
Hungary
Heart centre Semmelweis University
Budapest, Hungary, 1122
Latvia
Pauls Stradins Clinical University Hospital
Riga, Latvia, 1002
Netherlands
OLVG (Onze Lieve Vrouwe Gasthuis)
Amsterdam, Netherlands, 1091
Spain
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
Switzerland
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
Investigators
Principal Investigator: Stephan Windecker, MD University Hospital (Inselspital) / Bern / Switzerland
Principal Investigator: Thierry Lefèvre, MD Institute Hospitalier Jaques Cartier / Massy / France
  More Information

No publications provided

Responsible Party: Biotronik AG
ClinicalTrials.gov Identifier: NCT01356888     History of Changes
Other Study ID Numbers: C1004
Study First Received: May 18, 2011
Last Updated: August 8, 2013
Health Authority: Austria: Agency for Health and Food Safety
Austria: Ethikkommission
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes
Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission
Latvia: Institutional Review Board
Latvia: State Agency of Medicines
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Hungary: Research Ethics Medical Committee
Spain: Ethics Committee
Switzerland: Ethikkommission

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 August 28, 2014