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

• Conditions: Coronary Artery Disease; Acute Coronary Syndrome; Myocardial Infarction; Angina Pectoris
• Interventions: Device: Resolute Onyx

• Registration Number: NCT03151018
• Lead Sponsor: Seoul National University Hospital

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

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2016-07-21
• Status Verified: 2017-05
• Study First Submitted QC: 2017-05-10
• Last Update Submitted: 2017-05-10
• Study First Posted: 2017-05-12
• Last Update Posted: 2017-05-12
• Primary Completion: 2018-05
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Target lesion failure	12 months	Composite of cardiac death, non-fatal target vessel-related myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR)

Secondary Outcome Measures

Name	Time	Method
Rate of compliance and interruptions with prescribed adjunctive antiplatelet therapy	12 months, 3 years	we will estimate this outcome with relevant questionnaire
Stent thrombosis, very-late	1 year ~ up to 3 years	according to ARC definition
Clinical device and procedural success rate	intraoperative ( index PCI)	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
Stent thrombosis, acute	within 24 hours after index PCI	according to Academic Research Consortium (ARC) definition
Target vessel failure	12 months	Composite of cardiac death, non-fatal target vessel related myocardial infarction, and ischemia-driven target vessel revascularization (TVR)
Stent thrombosis, subacute	from 24 hours to 30 days after index PCI	according to ARC definition
Stent thrombosis, late	from 30 days to 1 year after index PCI	according to ARC definition
Composite rate of cardiac death and myocardial infarction	12 months, 3 years	as title
Composite rate of all-cause death and any myocardial infarction	12 months, 3 years	as title
Composite rate of all-cause death and any myocardial infarction, and any repeat revascularization	12 months, 3 years	as title

Trial Locations

Locations (16)

Soon Chun Hyang University Hospital Cheonan; 🇰🇷 Cheonan, Korea, Republic of

Myongji Hospital; 🇰🇷 Goyang, Korea, Republic of

Presbyterian Medical Center; 🇰🇷 Jeonju, Korea, Republic of

Chungbuk National University Hospital; 🇰🇷 Chonju, Korea, Republic of

Gyeongsang National University Hospital; 🇰🇷 Jinju, Korea, Republic of

Gangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Gangbuk Samsung Hospital; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Soonchunhyang University Hospital; 🇰🇷 Seoul, Korea, Republic of

Kwangju Veterans Hospital; 🇰🇷 Gwangju, Korea, Republic of

Kosin University Gospel Hospital; 🇰🇷 Busan, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of

Pusan National University Hospital; 🇰🇷 Pusan, Korea, Republic of

Gwangju Christian Hospital; 🇰🇷 Gwangju, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

St. Vincent's Hospital; 🇰🇷 Suwon, Korea, Republic of