The Study to Evaluate the Safety and Efficacy of the Onyx Family

Recruiting now

Conditions studied: Coronary Artery Disease

In brief

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

Key facts

Study ID

NCT06577896

Run by

Pusan National University Yangsan Hospital

People needed

500

Starts

2022-06-09

Expected to finish

2026-12-31

Last updated by the study team

2024-09-19

Who can join

Age: 75 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Pusan National University Yangsan Hospital — Yangsan, Gyeongsangnam-do, South Korea (enrolling)

Full record on ClinicalTrials.gov

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