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

Coronary Artery Disease Clinical Trial

— HOST-ONYX  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03151018
• Other study ID #: HOST-ONYX
• Status: Recruiting
• Phase: N/A
• First received: July 21, 2016
• Last updated: May 10, 2017
• Start date: May 2015
• Est. completion date: May 2021

Study information

• Verified date: May 2017
• Source: Seoul National University Hospital
• Contact: Hyo-soo Kim, MD, PhD
• Phone: +82-2-2072-2226
• Email: hyosoo[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: May 2021
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Age above 19

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

Exclusion Criteria:

Related Conditions & MeSH terms

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

Intervention

Device:
• Resolute Onyx

Locations

Country	Name	City	State
Korea, Republic of	Kosin University Gospel Hospital	Busan
Korea, Republic of	Soon Chun Hyang University Hospital Cheonan	Cheonan
Korea, Republic of	Chungbuk National University Hospital	Chonju
Korea, Republic of	Myongji Hospital	Goyang
Korea, Republic of	Gwangju Christian Hospital	Gwangju
Korea, Republic of	Kwangju Veterans Hospital	Gwangju
Korea, Republic of	Presbyterian Medical Center	Jeonju
Korea, Republic of	Gyeongsang National University Hospital	Jinju
Korea, Republic of	Pusan National University Hospital	Pusan
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Gangbuk Samsung Hospital	Seoul
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Soonchunhyang University Hospital	Seoul
Korea, Republic of	St. Vincent's Hospital	Suwon

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Medtronic

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target lesion failure	Composite of cardiac death, non-fatal target vessel-related myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR)	12 months
Secondary	Stent thrombosis, acute	according to Academic Research Consortium (ARC) definition	within 24 hours after index PCI
Secondary	Stent thrombosis, subacute	according to ARC definition	from 24 hours to 30 days after index PCI
Secondary	Stent thrombosis, late	according to ARC definition	from 30 days to 1 year after index PCI
Secondary	Stent thrombosis, very-late	according to ARC definition	1 year ~ up to 3 years
Secondary	Target vessel failure	Composite of cardiac death, non-fatal target vessel related myocardial infarction, and ischemia-driven target vessel revascularization (TVR)	12 months
Secondary	Composite rate of cardiac death and myocardial infarction	as title	12 months, 3 years
Secondary	Composite rate of all-cause death and any myocardial infarction	as title	12 months, 3 years
Secondary	Composite rate of all-cause death and any myocardial infarction, and any repeat revascularization	as title	12 months, 3 years
Secondary	Rate of compliance and interruptions with prescribed adjunctive antiplatelet therapy	we will estimate this outcome with relevant questionnaire	12 months, 3 years
Secondary	Clinical device and procedural success rate	device success : residual stenosis <30%, final thrombolysis in myocardial infarction (TIMI) flow grade III procedural success : device success + no adverse events immediate after the procedure	intraoperative ( index PCI)