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

May 10, 2017 updated by: Hyo-Soo Kim, Seoul National University Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of
        • Recruiting
        • Kosin University Gospel Hospital
      • Cheonan, Korea, Republic of
        • Recruiting
        • Soon Chun Hyang University Hospital Cheonan
        • Contact:
        • Principal Investigator:
          • Dong-Kyu Jin, MD,PhD
      • Chonju, Korea, Republic of
        • Recruiting
        • Chungbuk National University Hospital
      • Goyang, Korea, Republic of
        • Recruiting
        • Myongji Hospital
        • Contact:
          • Deok-Kyu Cho
      • Gwangju, Korea, Republic of
        • Recruiting
        • Gwangju Christian Hospital
        • Contact:
          • Seung Uk Lee
      • Gwangju, Korea, Republic of
      • Jeonju, Korea, Republic of
        • Recruiting
        • Presbyterian Medical Center
      • Jinju, Korea, Republic of
        • Recruiting
        • Gyeongsang National University Hospital
        • Contact:
        • Principal Investigator:
          • Choong-Hwan Cwak, MD,PhD
      • Pusan, Korea, Republic of
        • Recruiting
        • Pusan National University Hospital
      • Seongnam, Korea, Republic of
        • Recruiting
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Sub-Investigator:
          • Hae-Young Lee, MD, PhD
        • Sub-Investigator:
          • Hyun-Jae Cho, MD, PhD
        • Sub-Investigator:
          • Kyung-Woo Park, MD, PhD
        • Sub-Investigator:
          • Han-Mo Yang, MD, PhD
      • Seoul, Korea, Republic of
        • Recruiting
        • Gangnam Severance Hospital
        • Contact:
        • Principal Investigator:
          • Hyuk-Moon Kwon, MD,PhD
      • Seoul, Korea, Republic of
        • Recruiting
        • Samsung Medical Center
        • Contact:
        • Principal Investigator:
          • Hyun-Cheol Kwon, MD,PhD
      • Seoul, Korea, Republic of
        • Recruiting
        • Soonchunhyang University Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Gangbuk Samsung Hospital
      • Suwon, Korea, Republic of
        • Recruiting
        • St. Vincent's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All coronary arterial disease patients who received percutaneous coronary intervention with Resolute Onyx™ stent(s)

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Onyx
The patients who received PCI with Resolute Onyx stent(s)
Device: Resolute Onyx
Other Names:
  • Zotarolimus-eluting stent

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Target lesion failure
Time Frame: 12 months
Composite of cardiac death, non-fatal target vessel-related myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR)
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Target vessel failure
Time Frame: 12 months
Composite of cardiac death, non-fatal target vessel related myocardial infarction, and ischemia-driven target vessel revascularization (TVR)
12 months
Stent thrombosis, acute
Time Frame: within 24 hours after index PCI
according to Academic Research Consortium (ARC) definition
within 24 hours after index PCI
Stent thrombosis, subacute
Time Frame: from 24 hours to 30 days after index PCI
according to ARC definition
from 24 hours to 30 days after index PCI
Stent thrombosis, late
Time Frame: from 30 days to 1 year after index PCI
according to ARC definition
from 30 days to 1 year after index PCI
Stent thrombosis, very-late
Time Frame: 1 year ~ up to 3 years
according to ARC definition
1 year ~ up to 3 years
Composite rate of cardiac death and myocardial infarction
Time Frame: 12 months, 3 years
as title
12 months, 3 years
Composite rate of all-cause death and any myocardial infarction
Time Frame: 12 months, 3 years
as title
12 months, 3 years
Composite rate of all-cause death and any myocardial infarction, and any repeat revascularization
Time Frame: 12 months, 3 years
as title
12 months, 3 years
Rate of compliance and interruptions with prescribed adjunctive antiplatelet therapy
Time Frame: 12 months, 3 years
we will estimate this outcome with relevant questionnaire
12 months, 3 years
Clinical device and procedural success rate
Time Frame: 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
intraoperative ( index PCI)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medtronic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2015

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2018

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 21, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HOST-ONYX

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myocardial Infarction

Clinical Trials on Resolute Onyx

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings