Evaluating the safety and effectiveness of Onyx stents in elderly patients with coronary artery disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on elderly patients aged 75 years or older who are undergoing percutaneous coronary intervention with Onyx family drug-eluting stents. It aims to observe the safety and efficacy of transitioning from dual antiplatelet therapy to single therapy after one month of dual therapy. The study will monitor these patients for one year following the procedure to assess outcomes related to myocardial ischemia and coronary artery stenosis. The goal is to determine the best antiplatelet strategy for this vulnerable population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Pusan National University Yangsan Hospital
  Yangsan, Gyeongsangnam-do, South Korea Recruiting

Study contacts

• Principal investigator: Min Ku Chon, MD,PhD — Pusan National University Yangsan Hospital
• Study coordinator: Min Ku Chon, MD,PhD
• Email: chonmingu@gmail.com
• Phone: 82-10-2562-6258

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.