A Prospective Randomized Comparison of the BioFreedom Biolimus A9 Drug Coated Stent Versus the Gazelle Bare Metal Stent in Patients With High Risk of Bleeding.

Trial Profile

A Prospective Randomized Comparison of the BioFreedom Biolimus A9 Drug Coated Stent Versus the Gazelle Bare Metal Stent in Patients With High Risk of Bleeding.

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 03 Aug 2017

At a glance

  • Drugs Umirolimus (Primary)
  • Indications Acute coronary syndromes; Angina pectoris; Cardiovascular disorders; Coronary artery disease; Coronary artery restenosis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms LEADERS FREE
  • Sponsors Biosensors International Group
  • Most Recent Events

    • 17 May 2016 Results of sub-study (n=659) published in the European Heart Journal
    • 14 Oct 2015 Primary endpoint has been met. (Target vessel revascularisation event rate), as per an article published in the New England Journal of Medicine
    • 14 Oct 2015 Results published in the New England Journal of Medicine
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