None listed
Conditions
Interventions
Drug : Patients with coronary artery disease who receive the EluNIR™ stent undergo dual antiplatelet therapy (DAPT) for 3 months following percutaneous coronary intervention (PCI), followed by single
Sponsors
Hanyang University Seoul Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 19 years. 2. Patients with coronary artery disease who have successfully undergone PCI using the EluNIR stent. There are no restrictions on the number of lesions or vessels requiring treatment, nor on the lesion length. 3. Patients who voluntarily decide to participate in the study, provide written informed consent, and are willing and able to comply with follow-up visits and examination schedules.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding women. 2. Presence of cardiogenic shock. 3. Any co-morbid condition that may reduce life expectancy to less than 12 months. 4. History or presence of clinically significant medical conditions, such as psychiatric disorders, that may interfere with study participation or affect study outcomes. 5. Known allergy or hypersensitivity to protocol-required concomitant medications such as aspirin or clopidogrel, without the possibility of appropriate prophylactic management. 6. Patients unable to continue protocol-required medications following PCI, including: - Patients with galactose intolerance, lactase deficiency, or glucose-galactose malabsorption - Patients with moderate to severe hepatic impairment (e.g., Child-Pugh Class B or C) - Patients currently receiving, or planning to receive, oral anticoagulants (e.g., vitamin K antagonists or novel oral anticoagulants such as dabigatran, rivaroxaban, apixaban, or edoxaban), or other classes of antiplatelet agents (e.g., cilostazol) 7. Patients expected to be non-compliant with 3-month DAPT or long-term single antiplatelet therapy. 8. Participation in another clinical trial at the time of enrollment. 8. However, enrollment is permitted if, in the investigator’s judgment, it does not interfere with the assessments of this study. Participation in registry studies is allowed concurrently with this study. Any other condition, in the opinion of the investigator, that makes the patient unsuitable for the study or may increase the risk associated with participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Net Adverse Clinical Events (NACE) | — |
Secondary
| Measure | Time frame |
|---|---|
| MACCE (Major Adverse Cardiac and Cerebrovascular Events);BARC(Bleeding Academic Research Consortium) bleeding type =2;TLF(Target Lesion Failure): cardiac death, target lesion-related non-fatal MI, CD-TLR(Clinically Driven-Target Lesion Revascularization) | — |
Countries
Korea, Republic of
Contacts
Public ContactSeung Jin Ryu
Hanyang University Seoul Hospital
Outcome results
None listed