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Japan-USA Harmonized Assessment by Randomized, Multi-Center Study of OrbusNEich's Combo StEnt (Japan-USA HARMONEE): Assessment of a Novel DES Platform For Percutaneous Coronary Revascularization in Patients With Ischemic Coronary Disease and NSTEMI Acute Coronary Syndrome

Trial Profile

Japan-USA Harmonized Assessment by Randomized, Multi-Center Study of OrbusNEich's Combo StEnt (Japan-USA HARMONEE): Assessment of a Novel DES Platform For Percutaneous Coronary Revascularization in Patients With Ischemic Coronary Disease and NSTEMI Acute Coronary Syndrome

Status: Active, no longer recruiting
Phase of Trial: Phase II/III

Latest Information Update: 25 Sep 2019

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At a glance

  • Drugs Anti-CD34 monoclonal antibody/sirolimus (Primary) ; Everolimus
  • Indications Coronary artery disease; Coronary artery restenosis
  • Focus Proof of concept; Registrational; Therapeutic Use
  • Acronyms HARMONEE
  • Sponsors OrbusNeich
  • Most Recent Events

    • 25 Sep 2019 According to an OrbusNeich media release, this trial was conducted as a global clinical "proof-of-concept" project under the joint Japan PMDA-US FDA Harmonization by Doing initiative and to meet the Pilot trial requirements in the U.S.
    • 25 Sep 2019 According to an OrbusNeich media release, results of this study were presented in an European Heart Journal (2018).
    • 25 Sep 2019 Primary endpoint (Number of Participants With Target Vessel Failure (TVF): non-inferiority of COMBO Plus Stent compared to the EES comparator) has been met, according to an OrbusNeich media release.
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