Clinical trial NCT03151018: Effect and Efficacy of Onyx™, Zotarolimus-eluting Stent for Coronary Atherosclerosis
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Acute Coronary Syndrome
Myocardial Infarction
Angina Pectoris
Keywords: coronary artery disease
percutaneous coronary intervention
zotarolimus-eluting stents
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2017-05-12
Enrollment: 4000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All coronary arterial disease patients who received percutaneous coronary intervention with Resolute Onyx™ stent(s)

Brief 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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Target lesion failure
timeFrame: 12 months
Secondary outcomes:
measure: Stent thrombosis, acute
timeFrame: within 24 hours after index PCI
measure: Stent thrombosis, subacute
timeFrame: from 24 hours to 30 days after index PCI
measure: Stent thrombosis, late
timeFrame: from 30 days to 1 year after index PCI
measure: Stent thrombosis, very-late
timeFrame: 1 year ~ up to 3 years
measure: Target vessel failure
timeFrame: 12 months
measure: Composite rate of cardiac death and myocardial infarction
timeFrame: 12 months, 3 years
measure: Composite rate of all-cause death and any myocardial infarction
timeFrame: 12 months, 3 years
measure: Composite rate of all-cause death and any myocardial infarction, and any repeat revascularization
timeFrame: 12 months, 3 years
measure: Rate of compliance and interruptions with prescribed adjunctive antiplatelet therapy
timeFrame: 12 months, 3 years
measure: Clinical device and procedural success rate
timeFrame: intraoperative ( index PCI)
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Cheonan
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Cheonan
city: Chonju
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Goyang
country: Korea, Republic of
facility: Myongji Hospital
city: Gwangju
country: Korea, Republic of
facility: Gwangju Christian Hospital
city: Gwangju
country: Korea, Republic of
facility: Kwangju Veterans Hospital
city: Jeonju
country: Korea, Republic of
facility: Presbyterian Medical Center
city: Jinju
country: Korea, Republic of
facility: Gyeongsang National University Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Gangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Soonchunhyang University Hospital
city: Suwon
country: Korea, Republic of
facility: St. Vincent's Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hyo-soo Kim, MD, PhD
role: STUDY_CHAIR
References: