Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aged 75 or more | Elderly patients aged 75 years or older |
| |
| Eligible for interventional procedures | "Patients requiring PCI (Percutaneous Coronary Intervention) procedure |
| |
| Evidence of myocardial ischemia or coronary artery stenosis ≥ 50% | Patients with evidence of myocardial ischemia or coronary artery stenosis ≥ 50% on coronary angiography |
| |
| Able to take antiplatelets for at least 1 months after the procedure | Patients able to take antiplatelets after the procedure |
| |
| Patients who underwent coronary artery procedures with ZES stent | Patients who underwent coronary artery procedures with Onyx™ family stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Onyx family | Device | Safety and Efficacy of 1-Month DAPT in Elderly Patients at High Risk of Ischemia and Bleeding After Percutaneous Coronary Intervention with Onyx Family Stents |
| Measure | Description | Time Frame |
|---|---|---|
| MACCE at 12 months after coronary artery intervention | MACCE defined as a composite of all-cause mortality, MI, and cerebrovascular events at 12 months after the index procedure | 1 year after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| safety of procedures | All-cause mortality | 1 year after the procedure |
| safety of procedures | occurrence of Cardiac mortality | 1 year after the procedure |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Patients who underwent percutaneous coronary intervention using Onyx family stents in those aged 75 years or older
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Ku Chon, MD,PhD | Contact | 82-10-2562-6258 | chonmingu@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Min Ku Chon, MD,PhD | Pusan National University Yangsan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Yangsan Hospital | Recruiting | Yangsan | Gyeongsangnam-do | 50611 | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| safety of procedures | occurrence of myocardial infarction | 1 year after the procedure |
| safety of procedures | occurrence of Cerebrovascular events | 1 year after the procedure |
| safety of procedures | occurrence of Target vessel revascularization (TVR) event | 1 year after the procedure |
| safety of procedures | occurrence of Target lesion revascularization (TLR) | 1 year after the procedure |
| safety of procedures | occurrence of Stent thrombosis | 1 year after the procedure |
| safety of procedures | occurrence of Bleeding Academic Research Consortium (BARC) type 2 to 5 the procedure | 1 year after the procedure |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |