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NCT02073565 · ClinicalTrials.gov registry record · NA
HARMONEE - Japan-USA Harmonized Assessment by Randomized, Multi-Center Study of OrbusNEich's Combo StEnt
A NA study of Coronary Arteriosclerosis and Non ST Segment Elevation Acute Coronary Syndrome, sponsored by OrbusNeich.
- Completed
- Registry status
- NA
- Development phase
- 572
- Enrollment target
- 20
- Study locations
NCT02073565 is a NA study of Coronary Arteriosclerosis and Non ST Segment Elevation Acute Coronary Syndrome that has completed, run by OrbusNeich. The registered enrollment target is 572 participants, below the 666-participant average among 11 other Coronary Arteriosclerosis trials with a reported enrollment target (14% lower). The trial reports 20 study locations across 13 states.
The verdict
NCT02073565, a NA study of Coronary Arteriosclerosis and Non ST Segment Elevation Acute Coronary Syndrome, has completed, sponsored by OrbusNeich.
- COMPLETED
- Registry status
- NA
- Development phase
- 572 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DEVICE OrbusNeich Combo stent™
- DEVICE Everolimus Eluting Stent (EES)
Study Locations (20)
Florida
- Atlantic Clinical Research Collaborative-Cardiology - Lake Worth
- University of Miami - Miami
- Tallahassee Research Institute - Tallahassee
Fukuoka
- Saiseikai Fukuoka General Hospital - Fukoka-shi
- Kurume University Hospital - Kurume-shi
- Shinkoga Hospital - Kurume-shi
Georgia
- Emory University Hospital Midtown - Atlanta
- North Georgia Heart Foundation - Gainesville
New York
- Mount Sinai Medical Center - New York
- University of Rochester Medical Center-Strong Memorial Hospital - Rochester
North Carolina
- Duke University Medical Center - Durham
- Wake Forest Baptist Medical Center - Winston-Salem
District of Columbia
- MedStar Clinical Research Center - Washington D.C.
Maine
- Maine Medical Center - Portland
Maryland
- Washington Adventist Hospital - Takoma Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 572 participants |
| Start Date | 2014-02 |
| Est. Completion | 2021-12 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02073565
The ClinicalTrials.gov registry entry for NCT02073565 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 572 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 666-participant average among 11 other Coronary Arteriosclerosis trials with a reported enrollment target (14% lower). The listed sponsor is OrbusNeich, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Coronary Arteriosclerosis appearing as the primary indexed condition, and to 2 interventions - of which OrbusNeich Combo stent™ is the first listed.
NCT02073565 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Florida, Fukuoka, Georgia.
Frequently Asked Questions
What is clinical trial NCT02073565 about?
NCT02073565 is a clinical study titled "HARMONEE - Japan-USA Harmonized Assessment by Randomized, Multi-Center Study of OrbusNEich's Combo StEnt". 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.
What is the current status of trial NCT02073565?
This trial is currently completed. It is a NA study. The enrollment target is 572 participants. The study started on 2014-02. Estimated completion is 2021-12.
What conditions does trial NCT02073565 study?
This clinical trial studies the following conditions: Coronary Arteriosclerosis, Non ST Segment Elevation Acute Coronary Syndrome.
What interventions are being tested in trial NCT02073565?
The interventions under investigation include: OrbusNeich Combo stent™ (DEVICE), Everolimus Eluting Stent (EES) (DEVICE).
Who is sponsoring clinical trial NCT02073565?
This trial is sponsored by OrbusNeich, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02073565 being conducted?
This trial has 20 study locations across District of Columbia, Florida, Georgia, Maine, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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