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

Unknown

Conditions

Intervention / Treatment

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

Observational

Enrollment (Anticipated)

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

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
Intervention / Treatment
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

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

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

Seoul National University Hospital

Collaborators

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

May 1, 2015

Primary Completion (ANTICIPATED)

May 1, 2018

Study Completion (ANTICIPATED)

May 1, 2021

Study Registration Dates

First Submitted

July 21, 2016

First Submitted That Met QC Criteria

May 10, 2017

First Posted (ACTUAL)

May 12, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 12, 2017

Last Update Submitted That Met QC Criteria

May 10, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

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