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

Pusan National University Yangsan Hospital

Status: Enrolling

Conditions: Coronary Artery Disease

Treatments: Device: Onyx family

Study type: Observational

Funder types: Other

Identifiers

NCT06577896

BRONYX STUDY

Details and patient eligibility

About

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

Full 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

Enrollment: 500 estimated patients

Sex: All

Ages: 75 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

500 participants in 5 patient groups

Aged 75 or more

Description:

Elderly patients aged 75 years or older

Treatment:

Device: Onyx family

Eligible for interventional procedures

Description:

"Patients requiring PCI (Percutaneous Coronary Intervention) procedure

Treatment:

Device: Onyx family

Evidence of myocardial ischemia or coronary artery stenosis ≥ 50%

Description:

Patients with evidence of myocardial ischemia or coronary artery stenosis ≥ 50% on coronary angiography

Treatment:

Device: Onyx family

Able to take antiplatelets for at least 1 months after the procedure

Description:

Patients able to take antiplatelets after the procedure

Treatment:

Device: Onyx family

Patients who underwent coronary artery procedures with ZES stent

Description:

Patients who underwent coronary artery procedures with Onyx™ family stent

Treatment:

Device: Onyx family