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

Recruiting

• Conditions: Coronary Artery Disease
• Interventions: Device: Onyx family

• Registration Number: NCT06577896
• Lead Sponsor: Pusan National University Yangsan Hospital

Brief 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

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 Timeline

• Study Start: 2022-06-09
• Status Verified: 2024-08
• Study First Submitted: 2024-08-27
• Study First Submitted QC: 2024-08-27
• Last Update Submitted: 2024-08-27
• Study First Posted: 2024-08-29
• Last Update Posted: 2024-08-29
• Primary Completion: 2026-01-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients who underwent coronary artery procedures with ZES stent	Onyx family	Patients who underwent coronary artery procedures with Onyx™ family stent
Eligible for interventional procedures	Onyx family	"Patients requiring PCI (Percutaneous Coronary Intervention) procedure
Evidence of myocardial ischemia or coronary artery stenosis ≥ 50%	Onyx family	Patients with evidence of myocardial ischemia or coronary artery stenosis ≥ 50% on coronary angiography
Aged 75 or more	Onyx family	Elderly patients aged 75 years or older
Able to take antiplatelets for at least 1 months after the procedure	Onyx family	Patients able to take antiplatelets after the procedure

Primary Outcome Measures

Name	Time	Method
MACCE at 12 months after coronary artery intervention	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

Secondary Outcome Measures

Name	Time	Method
safety of procedures	1 year after the procedure	occurrence of Bleeding Academic Research Consortium (BARC) type 2 to 5 the procedure

Trial Locations

Locations (1)

Pusan National University Yangsan Hospital; 🇰🇷 Yangsan, Gyeongsangnam-do, Korea, Republic of