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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: Completed NA study of Coronary Arteriosclerosis and Non ST Segment Elevation Acute Coronary Syndrome, sponsored by OrbusNeich.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary clinical endpoint of Target Vessel Failure (TVF), defined as cardiac death, target-vessel myocardial infarction (MI), or ischemia-driven Target Vessel Revascularization(TVR) by percutaneous or surgical methods, at 1 year.
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 |
What the finished NCT02073565 record still lists
NCT02073565 is an interventional study that assigns participants to a tested intervention. The registered 572 participants enrollment target is mid-sized for trials with a published cap, below the 666-participant average among 11 other Coronary Arteriosclerosis trials with a reported enrollment target (14% lower).
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 names 20 study sites across 13 states, led by 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.
Learn More About Clinical Trials
Similar trials for Coronary Arteriosclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02073565's enrollment target sits among peer trials
572 5th of 11 higher than 7 of 11 other Coronary Arteriosclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Coronary Arteriosclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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