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

Trial Profile

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

Active, no longer recruiting
Phase of Trial: Phase IV

Latest Information Update: 02 Nov 2016

At a glance

  • Drugs Sirolimus (Primary) ; Everolimus
  • Indications Coronary artery disease; Coronary artery restenosis
  • Focus Therapeutic Use
  • Acronyms BIOFLOW-II
  • Sponsors BIOTRONIK
  • Most Recent Events

    • 30 May 2013 Positive outcome for primary endpoint reported at a late-breaking clinical trials session at the EuroPCR congress, according to a Biotronik media release. Data also reported in the media release.
    • 30 May 2013 Primary endpoint 'Non-inferiority between everolimus- and sirolimus-eluting stents in in-stent late lumen loss at 9 months' has been met.
    • 27 Mar 2012 Planned end date changed from 1 Jan 2017 to 1 Apr 2017 as reported by ClinicalTrials.gov.
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