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Completed Not applicable Interventional Results available

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

ClinicalTrials.gov ID: NCT02073565

Public ClinicalTrials.gov record NCT02073565. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 9:39 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a multi-center, single-blind, randomized, active-controlled, clinical trial in Percutaneous Coronary Intervention (PCI) subjects. Subjects will be randomized to receive the Combo stent as the investigational treatment arm or an Everolimus Eluting Stent (EES) as the active-control arm.

Study identification

NCT ID
NCT02073565
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
OrbusNeich
Industry
Enrollment
572 participants

Conditions and interventions

Eligibility (public fields only)

Age range
20 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 2014 (Type not available)
Primary completion
Jul 14, 2017 (Actual)
Completion
Dec 2021 (Actual)
Last update posted
May 13, 2022

2014 – 2021

United States locations

U.S. sites
17
U.S. states
12
U.S. cities
17
Facility City State ZIP Site status
MedStar Clinical Research Center Washington D.C. District of Columbia 20010 —
Atlantic Clinical Research Collaborative-Cardiology Lake Worth Florida 33462 —
University of Miami Miami Florida 33136 —
Tallahassee Research Institute Tallahassee Florida 32308 —
Emory University Hospital Midtown Atlanta Georgia 30308 —
North Georgia Heart Foundation Gainesville Georgia 30501 —
Maine Medical Center Portland Maine 04102 —
Washington Adventist Hospital Takoma Park Maryland 20912 —
Lahey Clinic Burlington Massachusetts 01805 —
North Mississippi Medical Center Tupelo Mississippi 38801 —
Mount Sinai Medical Center New York New York 10029 —
University of Rochester Medical Center-Strong Memorial Hospital Rochester New York 14642 —
Duke University Medical Center Durham North Carolina 27705 —
Wake Forest Baptist Medical Center Winston-Salem North Carolina 27157 —
The Ohio State University Medical Center Columbus Ohio 43210 —
Lehigh Valley Hospital Allentown Pennsylvania 18103 —
Vanderbilt University Medical Center Nashville Tennessee 37232 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 33 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02073565, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 13, 2022 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02073565 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →