Status:
RECRUITING
The Study to Evaluate the Safety and Efficacy of the Onyx Family
Lead Sponsor:
Pusan National University Yangsan Hospital
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
75-100 years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 9 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06577896
Start Date
June 9 2022
End Date
December 31 2026
Last Update
September 19 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, South Korea, 50611