The Study to Evaluate the Safety and Efficacy of the Onyx Family
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Onyx family.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease. Basic parameters: 75 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
Interventions
- Device 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
Primary outcome measures
- MACCE at 12 months after coronary artery intervention [Time frame: 1 year after the procedure]
Secondary outcome measures (8)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Pusan National University Yangsan Hospital — Yangsan
Identifiers
NCT: NCT06577896 · BRONYX STUDY