NCT05759676 Efficacy and Safety of Polymer-free Amphilimus-eluting Stent According to the Diabetes
| NCT ID | NCT05759676 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Korea University Anam Hospital |
| Condition | Diabetes Mellitus |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,800 participants |
| Start Date | 2023-03-09 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,800 participants in total. It began in 2023-03-09 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Age 19 or older * Patients who agreed to the research protocol and clinical follow-up plan, voluntarily decided to participate in this study, and gave written consent to the consent form ③ Patients who underwent coronary angioplasty by inserting Cre8™ or Cre8™ EVO stent for coronary artery disease for a lesion confirmed within the last 1 month 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 * Patients who visited the hospital due to cardiogenic shock and are predicted to have a low survival rate based on medical judgment ⑥ Subjects participating in medical device randomization research ⑦ Patients who underwent surgery using a stent other than Cre8™/Cre8™ EVO at the time of registration
Frequently Asked Questions
Who can join the NCT05759676 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Diabetes Mellitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05759676 currently recruiting?
Yes, NCT05759676 is actively recruiting participants. Visit ClinicalTrials.gov or contact Korea University Anam Hospital to inquire about joining.
Where is the NCT05759676 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT05759676 clinical trial?
NCT05759676 is sponsored by Korea University Anam Hospital. The trial plans to enroll 1,800 participants.
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