The Study to Evaluate the Safety and Efficacy of the Onyx Family
NCT ID: NCT06577896
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2022-06-09
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Aged 75 or more
Elderly patients aged 75 years or older
Onyx family
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
Eligible for interventional procedures
"Patients requiring PCI (Percutaneous Coronary Intervention) procedure
Onyx family
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
Evidence of myocardial ischemia or coronary artery stenosis ≥ 50%
Patients with evidence of myocardial ischemia or coronary artery stenosis ≥ 50% on coronary angiography
Onyx family
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
Able to take antiplatelets for at least 1 months after the procedure
Patients able to take antiplatelets after the procedure
Onyx family
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
Patients who underwent coronary artery procedures with ZES stent
Patients who underwent coronary artery procedures with Onyx™ family stent
Onyx family
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
Interventions
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Onyx family
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
75 Years
100 Years
ALL
No
Sponsors
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Pusan National University Yangsan Hospital
OTHER
Responsible Party
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Min Ku Chon
Associate Professor
Principal Investigators
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Min Ku Chon, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Pusan National University Yangsan Hospital
Locations
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Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BRONYX STUDY
Identifier Type: -
Identifier Source: org_study_id
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