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

NCT02073565 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 572

Last updated 2022-05-13

Study results available
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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

  • Coronary Arteriosclerosis
  • Non ST Segment Elevation Acute Coronary Syndrome

Interventions

DEVICE

OrbusNeich Combo stent™

The Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface.

DEVICE

Everolimus Eluting Stent (EES)

Everolimus Eluting Stent (EES) (Xience V, Xience Prime, Xience Xpedition stents, Abbott Vascular/Abbott Vascular Japan). Xience Prime inherited the clinical result of Xience V and is a product that obtains efficiency essentially equal to Xience V.

Sponsors & Collaborators

  • OrbusNeich Medical K.K.

    collaborator UNKNOWN

  • Duke Clinical Research Institute

    collaborator OTHER

  • OrbusNeich

    lead INDUSTRY

Principal Investigators

  • Mitchell W Krucoff, MD · Duke Clinical Research Institute

  • Shigeru Saito, MD · Shonan Kamakura General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2017-07-14
Completion
2021-12-31

Countries

  • United States
  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02073565 on ClinicalTrials.gov