Japan-USA Harmonized Assessment by Randomized, Multi-Center Study of OrbusNEich's Combo StEnt (HARMONEE) - Adventist HealthCare

Clinical Trial Details

HARMONEE

Japan-USA Harmonized Assessment by Randomized, Multi-Center Study of OrbusNEich's Combo StEnt (HARMONEE)

Purpose/Objective

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Full Trial Details: ClinicalTrials.gov

Condition: Coronary Artery Disease
Study Type: Interventional
Phase: Phase III
Study Start Date: 05/05/2015
Study Completion Date: TBD

This study is intended to demonstrate that the Combo stent platform shows superiority to an imputed BMS performance goal, noninferior effectiveness and safety vs best-in-class second-generation everolimus-eluting stent, and evidence of mechanistic activity of the anti-CD34-Ab EPC capture technology with healthy level of intimal tissue coverage superior to that of the best-in-class EES.

NCT Number
NCT02073565
Principal Investigator(s)
Thomas Wang, MD
Sponsor(s)
OrbusNeich
Participant Eligibility
  • Age: 20 - No Maximum
  • Gender: Male, Female

Location

  • Adventist HealthCare Washington Adventist Hospital
    7600 Carroll Avenue
    Takoma Park, MD 20912
    Main: 301-891-7600

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