An observational study in Diabetes Mellitus and Coronary Artery Disease, sponsored by Korea University Anam Hospital. Recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-04-04.
Sponsored by Korea University Anam Hospital · Observational
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 1,800 is above the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.
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Patient with coronary artery disease who is undergoing percutaneous coronary intervention
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 ③ 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
Patient with CAD who undergoing PCI with Cre8™/Cre8™ EVO drug-eluting stent
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
Time frame: 12 month
patient-oriented composite endpoint
composite of all-cause mortality, any myocardial infarction, and any revascularization in patient with DM and non-DM
Time frame: 12 month
Incidence of all-cause mortality
Incidence of all-cause mortality in patient with DM and non-DM
Time frame: 12 month
Incidence of all-cause cardiac death
Incidence of all-cause cardiac death in patient with DM and non-DM
Time frame: 12 month
Incidence of all-cause non-cardiac death
Incidence of all-cause non-cardiac death in patient with DM and non-DM
Time frame: 12 month
Incidence of any myocardial infarction
Incidence of any myocardial infarction in patient with DM and non-DM
Time frame: 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
Time frame: 12 month
Incidence of any revascularization
Incidence of any revascularization in patient with DM and non-DM
Time frame: 12 month
Incidence of target lesion revascularization
Incidence of target lesion revascularization in patient with DM and non-DM
Time frame: 12 month
Incidence of stent thrombosis
Incidence of stent thrombosis in patient with DM and non-DM
Time frame: 12 month
Lesion success rate
less than 50% of residual stenosis after all procedure in patient with DM and non-DM
Time frame: 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
Time frame: 1 month
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
No publications or documents are linked to this record.
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Korea University Anam Hospital