At a glance
ClinicalIndex Comparison Record- ✓Age at least 20 years at randomization
- ✓Clinical or functional evidence of myocardial ischemia (stable or unstable angina, stabilized NSTEMI, positive functional study, abnormal FFR, or ECG changes consistent with ischemia)
- ✓Acceptable candidate with anatomy suitable for PCI with a DES
- ✓Target lesions in native coronary artery with diameter 2.5–3.5 mm, up to 3 de novo lesions, maximum 2 per epicardial vessel, maximum 2 target vessels
- ✕STEMI at index presentation or within 7 days of screening
- ✕Current unstable arrhythmias, intractable angina with ECG changes, or shock requiring pressors or mechanical assist device
- ✕Known LVEF less than 30%
- ✕Prior heart or organ transplant or on transplant waiting list
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating OrbusNeich Combo stent™ and Everolimus Eluting Stent (EES) for Coronary Arteriosclerosis and Non ST Segment Elevation Acute Coronary Syndrome. Completed, enrolled 572 participants across 50 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.