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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

May 18, 2011
August 8, 2013
May 2011
July 2013   (final data collection date for primary outcome measure)
Late Lumen Loss [ Time Frame: 9 months post index procedure ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01356888 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of the Orsiro Drug Eluting Stent System
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Disease
  • Device: Percutaneous Coronary Intervention (Abbott Laboratories - Xience Prime DES)
    Stenting
  • Device: Percutaneous Coronary Intervention (Orsiro DES)
    stenting
  • Active Comparator: Abbott Laboratories - Xience Prime DES
    Intervention: Device: Percutaneous Coronary Intervention (Abbott Laboratories - Xience Prime DES)
  • Experimental: Biotronik - Orsiro DES
    Intervention: Device: Percutaneous Coronary Intervention (Orsiro DES)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
440
April 2017
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   France,   Germany,   Hungary,   Latvia,   Netherlands,   Spain,   Switzerland
 
NCT01356888
C1004
Yes
Biotronik AG
Biotronik AG
Not Provided
Principal Investigator: Stephan Windecker, MD University Hospital (Inselspital) / Bern / Switzerland
Principal Investigator: Thierry Lefèvre, MD Institute Hospitalier Jaques Cartier / Massy / France
Biotronik AG
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP