Effect and Efficacy of Onyx™, Zotarolimus-eluting Stent for Coronary Atherosclerosis (HOST-ONYX)

Seoul National University

Status: Unknown

Conditions: Coronary Artery Disease; Acute Coronary Syndrome; Angina Pectoris; Myocardial Infarction

Treatments: Device: Resolute Onyx

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03151018

HOST-ONYX

Details and patient eligibility

About

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.

Full 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

Enrollment: 4,000 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age above 19
• Patients who received PCI with Resolute Onyx™ stent(s)

Exclusion criteria

• None

Trial design

4,000 participants in 1 patient group

Onyx

Description:

The patients who received PCI with Resolute Onyx stent(s)

Treatment:

Device: Resolute Onyx