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
| Name | Class |
|---|---|
| Diomedical | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Drug-eluting stents (DES) have been found to reduce the rate of stent restenosis compared to bare metal stents (BMS), but the first generation DES caused an increase in stent thrombosis. The second generation DES, including the Cre8Evo stent, has been designed to address these issues. The Cre8Evo stent is made of cobalt chromium and releases the drug amphilimus into the vessel wall, which is quickly absorbed and then lost, creating a BMS-like form. The Cre8Evo stent does not contain polymers and does not induce an inflammatory response. It inhibits cdk2 and RhoA, reducing the proliferation and migration of vascular smooth muscle cells. In diabetic patients, the Cre8Evo stent showed superior results in suppressing late proliferation compared to conventional DES. The Cre8Evo stent has been found to be safe and effective in clinical studies, and it has a superior effect in the clinical course of diabetic patients compared to other stents. The purpose of the study is to evaluate the effectiveness and safety of the Cre8Evo stent in actual clinical practice, specifically comparing outcomes in patients with and without diabetes.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cre8â„¢/Cre8â„¢ EVO drug-eluting stent | Device | Patient with CAD who undergoing PCI with Cre8â„¢/Cre8â„¢ EVO drug-eluting stent |
| Measure | Description | Time Frame |
|---|---|---|
| Target lesion failure(Device-oriented composite endpoints) | composite of cardiac death, any myocardial infarction not clearly attributatble to a non-target vessel, and clinical indicated target lesion revascularization in patient with DM and non-DM | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| patient-oriented composite endpoint | composite of all-cause mortality, any myocardial infarction, and any revascularization in patient with DM and non-DM | 12 month |
| Incidence of all-cause mortality |
Not provided
Inclusion Criteria:
Age 19 or older
Exclusion Criteria:
Patients with known hypersensitivity or contraindications to the following drugs or substances: heparin, aspirin, clopidogrel, amphilimus, cobalt chrome, stainless steel nickel, 316L metal, and contrast media If it can be controlled by pheniramine and pheniramine, registration is possible, but if there is known anaphylaxis, it is excluded.)
Pregnant women, lactating women, or women of childbearing age who are planning to become pregnant during the study period â‘¢ Patients who are planning surgery to stop antiplatelet drugs within 12 months from registration
Patients whose remaining life expectancy is expected to be less than 1 year
Not provided
Not provided
Not provided
Patient with coronary artery disease who is undergoing percutaneous coronary intervention
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Anam Hospital | Recruiting | Seoul | 136-705 | South Korea |
The subject identification information used in the study will be coded and managed so that personal identification is impossible. Documents and materials related to this study will be stored in a locked place designated by the research director. In accordance with Article 15 of the Enforcement Rules of the Bioethics and Safety Act, research-related records are planned to be kept for 3 years from the time the research is completed, and documents that have passed the retention period will be destroyed according to the relevant grounds.
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Incidence of all-cause mortality in patient with DM and non-DM
| 12 month |
| Incidence of all-cause cardiac death | Incidence of all-cause cardiac death in patient with DM and non-DM | 12 month |
| Incidence of all-cause non-cardiac death | Incidence of all-cause non-cardiac death in patient with DM and non-DM | 12 month |
| Incidence of any myocardial infarction | Incidence of any myocardial infarction in patient with DM and non-DM | 12 month |
| Incidence of any myocardial infarction not clearly attributatble to a non-target vessel | Incidence of any myocardial infarction not clearly attributatble to a non-target vessel in patient with DM and non-DM | 12 month |
| Incidence of any revascularization | Incidence of any revascularization in patient with DM and non-DM | 12 month |
| Incidence of target lesion revascularization | Incidence of target lesion revascularization in patient with DM and non-DM | 12 month |
| Incidence of stent thrombosis | Incidence of stent thrombosis in patient with DM and non-DM | 12 month |
| Lesion success rate | less than 50% of residual stenosis after all procedure in patient with DM and non-DM | the day of procedure |
| Procedural success rate | composite of less than 50% of residual stenosis after all procedure, no in-hospital event including death, MI, revascularization in patient with DM and non-DM | 1 month |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |