Actively Recruiting
Efficacy and Safety of Polymer-free Amphilimus-eluting Stent According to the Diabetes
Led by Korea University Anam Hospital · Updated on 2024-04-04
1800
Participants Needed
1
Research Sites
199 weeks
Total Duration
On this page
Sponsors
K
Korea University Anam Hospital
Lead Sponsor
D
Diomedical
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Polymer-free Amphilimus-eluting Stent According to the Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Patients who underwent coronary angioplasty by inserting Cre81/Cre81 EVO stent for coronary artery disease for a lesion confirmed within the last 1 month
You will not qualify if you...
- Patients with known hypersensitivity or contraindications to heparin, aspirin, clopidogrel, amphilimus, cobalt chrome, stainless steel nickel, 316L metal, or contrast media (unless controlled by pheniramine; known anaphylaxis excluded)
- Pregnant women, lactating women, or women planning to become pregnant during the study
- Patients planning surgery that requires stopping antiplatelet drugs within 12 months from registration
- Patients with life expectancy less than 1 year
- Patients who visited the hospital due to cardiogenic shock with expected low survival
- Subjects participating in medical device randomization research
- Patients who underwent surgery using a stent other than Cre81/Cre81 EVO at the time of registration
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Korea University Anam Hospital
Seoul, South Korea, 136-705
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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