Coronary Artery DiseaseHOST-ONYXNCT03151018
Effect and Efficacy of Onyx™, Zotarolimus-eluting Stent for Coronary Atherosclerosis
An observational study of Coronary Artery Disease and Acute Coronary Syndrome, run by Seoul National University Hospital at 16 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease, Acute Coronary Syndrome, Myocardial Infarction
- What is being tested?
- Resolute Onyx
- Type of treatment
- Medical device
- How many people
- 4,000 participants
- Where
- 16 sitesSouth Korea
- Study dates
- May 2015to May 2021
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All coronary arterial disease patients who received percutaneous coronary intervention with Resolute Onyx™ stent(s)
Who may be able to join
- Age above 19
- Patients who received PCI with Resolute Onyx™ stent(s)
Who cannot join
- None
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
South Korea16 sites, 16 recruiting
- Recruiting
Kosin University Gospel Hospital
Busan
Jeong Ho Heo
- Recruiting
Soon Chun Hyang University Hospital Cheonan
Cheonan
Dong-Kyo Jin, MD,PhD, bluesky@schch.co.kr
Dong-Kyu Jin, MD,PhD
- Recruiting
Myongji Hospital
Goyang
Deok-Kyu Cho
- Recruiting
Gwangju Christian Hospital
Gwangju
Seung Uk Lee
- Recruiting
Kwangju Veterans Hospital
Gwangju
Won Kim, MD,PhD, mylovekw@hanmail.net
Won Kim, MD,PhD
- Recruiting
Chungbuk National University Hospital
Jeonju
Jang-Hwan Bae, MD,PhD, drcorazon@hanmail.net
Jang-Hwan Bae, MD,PhD
- Recruiting
Presbyterian Medical Center
Jeonju
Je-Young Rhew, MD,PhD, jkrhew@hanafos.com
Je-Young Rhew, MD,PhD
- Recruiting
Gyeongsang National University Hospital
Jinju
Choong-Hwan Cwak, MD,PhD, cwakch@korea.com
Choong-Hwan Cwak, MD,PhD
- Recruiting
Pusan National University Hospital
Pusan
Han-Cheol Lee, MD,PhD, glaraone@hanmail.net
Han-Cheol Lee, MD,PhD
- Recruiting
Seoul National University Bundang Hospital
Seongnam
Dong-Ju Choi, MD,PhD, djchoi@snu.ac.kr
Dong-Ju Choi, MD,PhD
- Recruiting
Gangbuk Samsung Hospital
Seoul
Jin-Ho Kang, MD,PhD, jinho2.kang@samsung.com
Jin-Ho Kang, MD,PhD
- Recruiting
Gangnam Severance Hospital
Seoul
Hyuk-Moon Kwon, MD,PhD, kwonhm@yuhs.ac
Hyuk-Moon Kwon, MD,PhD
- Recruiting
Samsung Medical Center
Seoul
Hyun-Cheol Kwon, MD,PhD, hcgwon@skku.edu
Hyun-Cheol Kwon, MD,PhD
- Recruiting
Seoul National University Hospital
Seoul
Hyo-Soo Kim, MD, PhD, 82-2-2072-2226, hyosoo@snu.ac.kr
Hyo-soo Kim, MD, PhD
- Recruiting
Soonchunhyang University Hospital
Seoul
Min-Soo Hyon, MD,PhD, mshyon@hosp.sch.ac.kr
Min-Soo Hyon, MD,PhD
- Recruiting
St. Vincent's Hospital
Suwon
Geon-Woong Moon, MD,PhD, cardiomoon@gmail.com
Geon-Woong Moon, MD,PhD
About this study
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
The objectives of this study are
- To establish a prospective registry of the whole patients who received percutaneous coronary intervention with Resolute Onyx™ stent.
- To evaluate the long-term efficacy and safety of coronary stenting with the Resolute Onyx™ stent.
- 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.
Read the detailed description
Secondary endpoints are
- 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),
- Target vessel failure
- Composite rate of cardiac death and any MI, 3 years
- Composite rate of all death and any MI
- Composite rate of all death, any MI, and any repeat revascularization
- Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy
- Clinical device and procedural success
- Being tested
- Resolute Onyx
- Keywords
- coronary artery disease, percutaneous coronary intervention, zotarolimus-eluting stents
- Medical subject headings
- Coronary Artery Disease, Acute Coronary Syndrome, Myocardial Infarction, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resolute OnyxDevice
Also called Zotarolimus-eluting stent
| Study group | Role | What they receive |
|---|---|---|
| Onyx | The patients who received PCI with Resolute Onyx stent(s) Receives: Device: Resolute Onyx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target lesion failure
Composite of cardiac death, non-fatal target vessel-related myocardial infarction (MI), and ischemia-driven target lesion revascularization (TLR)
Measured: 12 months
Secondary outcomes (10)
Stent thrombosis, acute
according to Academic Research Consortium (ARC) definition
Measured: within 24 hours after index PCI
Stent thrombosis, subacute
according to ARC definition
Measured: from 24 hours to 30 days after index PCI
Stent thrombosis, late
according to ARC definition
Measured: from 30 days to 1 year after index PCI
Stent thrombosis, very-late
according to ARC definition
Measured: 1 year ~ up to 3 years
Target vessel failure
Composite of cardiac death, non-fatal target vessel related myocardial infarction, and ischemia-driven target vessel revascularization (TVR)
Measured: 12 months
Composite rate of cardiac death and myocardial infarction
as title
Measured: 12 months, 3 years
Composite rate of all-cause death and any myocardial infarction
as title
Measured: 12 months, 3 years
Composite rate of all-cause death and any myocardial infarction, and any repeat revascularization
as title
Measured: 12 months, 3 years
Rate of compliance and interruptions with prescribed adjunctive antiplatelet therapy
we will estimate this outcome with relevant questionnaire
Measured: 12 months, 3 years
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
Measured: intraoperative ( index PCI)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study startMay 2015
- Primary completionMay 2018 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Hyo-Soo Kim, Seoul National University Hospital
- Investigators
- Hyo-soo Kim, MD, PhD, Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03151018
- Sponsor's protocol ID
- HOST-ONYX
- Acronym
- HOST-ONYX
- Status last verified
- May 2017
- First submitted
- 21 Jul 2016
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03151018
- Acronym / sponsor ID
- HOST-ONYX / HOST-ONYX
- Keywords
- coronary artery disease, percutaneous coronary intervention, zotarolimus-eluting stents
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- May 2015
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 12 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are
- To establish a prospective registry of the whole patients who received percutaneous coronary intervention with Resolute Onyx™ stent.
- To evaluate the long-term efficacy and safety of coronary stenting with the Resolute Onyx™ stent.
- 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
- 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),
- Target vessel failure
- Composite rate of cardiac death and any MI, 3 years
- Composite rate of all death and any MI
- Composite rate of all death, any MI, and any repeat revascularization
- Compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy
- Clinical device and procedural success
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Onyx | – | Device: Resolute OnyxThe patients who received PCI with Resolute Onyx stent(s) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All coronary arterial disease patients who received percutaneous coronary intervention with Resolute Onyx™ stent(s)
Key inclusion criteria (2 listed)
- Age above 19
- Patients who received PCI with Resolute Onyx™ stent(s)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resolute OnyxAlso: Zotarolimus-eluting stent | Device | Onyx |
Primary outcome
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)
10 secondary outcomes
Stent thrombosis, acute
Time frame: within 24 hours after index PCI
Stent thrombosis, subacute
Time frame: from 24 hours to 30 days after index PCI
Stent thrombosis, late
Time frame: from 30 days to 1 year after index PCI
Stent thrombosis, very-late
Time frame: 1 year ~ up to 3 years
Target vessel failure
Time frame: 12 months
Composite rate of cardiac death and myocardial infarction
Time frame: 12 months, 3 years
Composite rate of all-cause death and any myocardial infarction
Time frame: 12 months, 3 years
Composite rate of all-cause death and any myocardial infarction, and any repeat revascularization
Time frame: 12 months, 3 years
Rate of compliance and interruptions with prescribed adjunctive antiplatelet therapy
Time frame: 12 months, 3 years
Clinical device and procedural success rate
Time frame: intraoperative ( index PCI)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyo-soo Kim, MD, PhD study chair
Seoul National University Hospital
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Acute Coronary Syndrome, run by Seoul National University Hospital at 16 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyo-soo Kim, MD, PhD (+82-2-2072-2226, hyosoo@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target lesion failure (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2017.