NCT03151018

Effect and Efficacy of Onyx™, Zotarolimus-eluting Stent for Coronary Atherosclerosis

Harmonizing Optimal Strategy for Treatment of Coronary Atherosclerotic Lesions - Registry-based Study on the Effect and Safety of Onyx™, Zotarolimus-eluting Stent for Coronary Atherosclerotic Lesions: HOST-Onyx Registry

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 4,000 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study are 1. To establish a prospective registry of the whole patients who received percutaneous coronary intervention with Resolute Onyx™ stent. 2. To evaluate the long-term efficacy and safety of coronary stenting with the Resolute Onyx™ stent. 3. To compare the long-term efficacy and safety of coronary stenting between the Resolute Onyx™ stent and other contemporary drug-eluting stents which had established their own registry.

Detailed description

Secondary endpoints are 1. Stent thrombosis-24 hours(acute), 30 days(subacute), 1 year(late), every 1 year till 3 years(very-late) after index PCI (percutaneous coronary intervention), 2. Target vessel failure 3. Composite rate of cardiac death and any MI, 3 years 4. Composite rate of all death and any MI 5. Composite rate of all death, any MI, and any repeat revascularization 6. Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy 7. Clinical device and procedural success

Conditions

• Coronary Artery Disease
• Acute Coronary Syndrome
• Myocardial Infarction
• Angina Pectoris

Interventions

Type	Name	Description
DEVICE	Resolute Onyx

Timeline

• Start date: 2015-05-01
• Primary completion: 2018-05-01
• Completion: 2021-05-01
• First posted: 2017-05-12
• Last updated: 2017-05-12

Locations

16 sites across 1 country: South Korea