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

NCT ID: NCT03151018

Last Updated: 2017-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2021-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Artery Disease Acute Coronary Syndrome Myocardial Infarction Angina Pectoris

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Onyx

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

Resolute Onyx

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Resolute Onyx

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Zotarolimus-eluting stent

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* None
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medtronic

INDUSTRY

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hyo-Soo Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hyo-soo Kim, MD, PhD

Role: STUDY_CHAIR

Seoul National University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kosin University Gospel Hospital

Busan, , South Korea

Site Status RECRUITING

Soon Chun Hyang University Hospital Cheonan

Cheonan, , South Korea

Site Status RECRUITING

Myongji Hospital

Goyang, , South Korea

Site Status RECRUITING

Gwangju Christian Hospital

Gwangju, , South Korea

Site Status RECRUITING

Kwangju Veterans Hospital

Gwangju, , South Korea

Site Status RECRUITING

Chungbuk National University Hospital

Jeonju, , South Korea

Site Status RECRUITING

Presbyterian Medical Center

Jeonju, , South Korea

Site Status RECRUITING

Gyeongsang National University Hospital

Jinju, , South Korea

Site Status RECRUITING

Pusan National University Hospital

Pusan, , South Korea

Site Status RECRUITING

Seoul National University Bundang Hospital

Seongnam, , South Korea

Site Status RECRUITING

Gangbuk Samsung Hospital

Seoul, , South Korea

Site Status RECRUITING

Gangnam Severance Hospital

Seoul, , South Korea

Site Status RECRUITING

Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Soonchunhyang University Hospital

Seoul, , South Korea

Site Status RECRUITING

St. Vincent's Hospital

Suwon, , South Korea

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Hyo-soo Kim, MD, PhD

Role: CONTACT

+82-2-2072-2226

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jeong Ho Heo

Role: primary

Dong-Kyo Jin, MD,PhD

Role: primary

Deok-Kyu Cho

Role: primary

Seung Uk Lee

Role: primary

Won Kim, MD,PhD

Role: primary

Jang-Hwan Bae, MD,PhD

Role: primary

Je-Young Rhew, MD,PhD

Role: primary

Choong-Hwan Cwak, MD,PhD

Role: primary

Han-Cheol Lee, MD,PhD

Role: primary

Dong-Ju Choi, MD,PhD

Role: primary

Jin-Ho Kang, MD,PhD

Role: primary

Hyuk-Moon Kwon, MD,PhD

Role: primary

Hyun-Cheol Kwon, MD,PhD

Role: primary

Hyo-Soo Kim, MD, PhD

Role: primary

82-2-2072-2226

Min-Soo Hyon, MD,PhD

Role: primary

Geon-Woong Moon, MD,PhD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HOST-ONYX

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

GENOSS Coronary Stent Clinical Trial
NCT05444452 RECRUITING NA