Coronary Artery DiseaseNCT06577896
The Study to Evaluate the Safety and Efficacy of the Onyx Family
An observational study of Coronary Artery Disease, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial summary
Observation of the safety and efficacy of 1-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention using Onyx family stents in elderly patients aged 75 years or older Read more about this study
- Who is it for?
- Ages 75 to 100 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Onyx family
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Jun 2022to 31 Dec 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients who underwent percutaneous coronary intervention using Onyx family stents in those aged 75 years or older
Who may be able to join
- Aged 75 or more.
- Eligible for interventional procedures.
- Evidence of myocardial ischemia or coronary artery stenosis ≥ 50%.
- Able to take antiplatelets for at least 1 months after the procedure.
- Patients who underwent coronary artery procedures with ZES (Medtronic, Minneapolis, MN, Onyx™ family) stent.
Who cannot join
- The patient has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, zotarolimus, and contrast media (patients with documented sensitivity to contrast media which can be effectively premedicated with steroids and diphenhydramine [eg, rash] may be enrolled. Those with true anaphylaxis to prior contrast media, however, should not be enrolled).
- Patients with active pathologic bleeding.
- Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
- History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia).
- Noncardiac comorbid conditions are present with life expectancy \<1 year or that may result in protocol noncompliance (per site investigator\'s medical judgment).
- Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 50611
Min Ku Chon, MD,PhD, 82-10-2562-6258, chonmingu@gmail.com
About this study
Official title: Safety and Efficacy of 1-month Dual Antiplatelet Therapy in High Bleeding and Ischemic Risk Elderly Patients With Coronary Artery Disease After Implantation of Zotarolimus-eluting Coronary Stent System (Onyx Family, Medtronic, Minneapolis, MN); A Multicenter, Prospective, Observational Study
Observation of the safety and efficacy of 1-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention using Onyx family stents in elderly patients aged 75 years or older
Read the detailed description
For elderly patients aged 75 years or older undergoing percutaneous coronary intervention with Onyx family drug-eluting stents, observe the safety and efficacy of transitioning from dual antiplatelet therapy to single therapy for one year after one month of dual antiplatelet therapy
- Conditions
- Coronary Artery Disease
- Being tested
- Onyx family
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Onyx familyDevice
Also called Onyx frontier, Resolute Onyx
Safety and Efficacy of 1-Month DAPT in Elderly Patients at High Risk of Ischemia and Bleeding After Percutaneous Coronary Intervention with Onyx Family Stents
| Study group | Role | What they receive |
|---|---|---|
| Aged 75 or more | Elderly patients aged 75 years or older Receives: Device: Onyx family | |
| Eligible for interventional procedures | "Patients requiring PCI (Percutaneous Coronary Intervention) procedure Receives: Device: Onyx family | |
| Evidence of myocardial ischemia or coronary artery stenosis ≥ 50% | Patients with evidence of myocardial ischemia or coronary artery stenosis ≥ 50% on coronary angiography Receives: Device: Onyx family | |
| Able to take antiplatelets for at least 1 months after the procedure | Patients able to take antiplatelets after the procedure Receives: Device: Onyx family | |
| Patients who underwent coronary artery procedures with ZES stent | Patients who underwent coronary artery procedures with Onyx™ family stent Receives: Device: Onyx family |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACCE at 12 months after coronary artery intervention
MACCE defined as a composite of all-cause mortality, MI, and cerebrovascular events at 12 months after the index procedure
Measured: 1 year after the procedure
Secondary outcomes (8)
safety of procedures
All-cause mortality
Measured: 1 year after the procedure
safety of procedures
occurrence of Cardiac mortality
Measured: 1 year after the procedure
safety of procedures
occurrence of myocardial infarction
Measured: 1 year after the procedure
safety of procedures
occurrence of Cerebrovascular events
Measured: 1 year after the procedure
safety of procedures
occurrence of Target vessel revascularization (TVR) event
Measured: 1 year after the procedure
safety of procedures
occurrence of Target lesion revascularization (TLR)
Measured: 1 year after the procedure
safety of procedures
occurrence of Stent thrombosis
Measured: 1 year after the procedure
safety of procedures
occurrence of Bleeding Academic Research Consortium (BARC) type 2 to 5 the procedure
Measured: 1 year after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start9 Jun 2022
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Dec 2026 (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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Ku Chon, Pusan National University Yangsan Hospital
- Investigators
- Min Ku Chon, MD,PhD, Principal investigator, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06577896
- Sponsor's protocol ID
- BRONYX STUDY
- Status last verified
- Sep 2024
- First submitted
- 27 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of 1-month Dual Antiplatelet Therapy in High Bleeding and Ischemic Risk Elderly Patients With Coronary Artery Disease After Implantation of Zotarolimus-eluting Coronary Stent System (Onyx Family, Medtronic, Minneapolis, MN); A Multicenter, Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT06577896
- Acronym / sponsor ID
- BRONYX STUDY
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 9 Jun 2022 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Aug 2024 (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.
Observation of the safety and efficacy of 1-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention using Onyx family stents in elderly patients aged 75 years or older
Detailed description
For elderly patients aged 75 years or older undergoing percutaneous coronary intervention with Onyx family drug-eluting stents, observe the safety and efficacy of transitioning from dual antiplatelet therapy to single therapy for one year after one month of dual antiplatelet therapy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Aged 75 or more | – | Device: Onyx familyElderly patients aged 75 years or older |
| Eligible for interventional procedures | – | Device: Onyx family"Patients requiring PCI (Percutaneous Coronary Intervention) procedure |
| Evidence of myocardial ischemia or coronary artery stenosis ≥ 50% | – | Device: Onyx familyPatients with evidence of myocardial ischemia or coronary artery stenosis ≥ 50% on coronary angiography |
| Able to take antiplatelets for at least 1 months after the procedure | – | Device: Onyx familyPatients able to take antiplatelets after the procedure |
| Patients who underwent coronary artery procedures with ZES stent | – | Device: Onyx familyPatients who underwent coronary artery procedures with Onyx™ family stent |
Who may qualify
- Ages
- 75 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients who underwent percutaneous coronary intervention using Onyx family stents in those aged 75 years or older
Key inclusion criteria (5 listed)
- Aged 75 or more.
- Eligible for interventional procedures.
- Evidence of myocardial ischemia or coronary artery stenosis ≥ 50%.
- Able to take antiplatelets for at least 1 months after the procedure.
- Patients who underwent coronary artery procedures with ZES (Medtronic, Minneapolis, MN, Onyx™ family) stent.
Key exclusion criteria (6 listed)
- The patient has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, zotarolimus, and contrast media (patients with documented sensitivity to contrast media which can be effectively premedicated with steroids and diphenhydramine [eg, rash] may be enrolled. Those with true anaphylaxis to prior contrast media, however, should not be enrolled).
- Patients with active pathologic bleeding.
- Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
- History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia).
- Noncardiac comorbid conditions are present with life expectancy \<1 year or that may result in protocol noncompliance (per site investigator\'s medical judgment).
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 |
|---|---|---|
| Onyx familyAlso: Onyx frontier, Resolute OnyxSafety and Efficacy of 1-Month DAPT in Elderly Patients at High Risk of Ischemia and Bleeding After Percutaneous Coronary Intervention with Onyx Family Stents | Device | Able to take antiplatelets for at least 1 months after the procedure, Aged 75 or more, Eligible for interventional procedures, Evidence of myocardial ischemia or coronary artery stenosis ≥ 50%, Patients who underwent coronary artery procedures with ZES stent |
Primary outcome
MACCE at 12 months after coronary artery intervention
Time frame: 1 year after the procedure
MACCE defined as a composite of all-cause mortality, MI, and cerebrovascular events at 12 months after the index procedure
8 secondary outcomes
safety of procedures
Time frame: 1 year after the procedure
safety of procedures
Time frame: 1 year after the procedure
safety of procedures
Time frame: 1 year after the procedure
safety of procedures
Time frame: 1 year after the procedure
safety of procedures
Time frame: 1 year after the procedure
safety of procedures
Time frame: 1 year after the procedure
safety of procedures
Time frame: 1 year after the procedure
safety of procedures
Time frame: 1 year after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Min Ku Chon, MD,PhD principal investigator
Pusan National University Yangsan Hospital
1 site 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, run by Pusan National University Yangsan Hospital at 1 site 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Min Ku Chon, MD,PhD (82-10-2562-6258, chonmingu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACCE at 12 months after coronary artery intervention (time frame: 1 year after the procedure). 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 19 Sep 2024.