Efficacy and Safety of Polymer-free Amphilimus-eluting Stent According to the Diabetes

NCT05759676 · tracked via the Priya Life Science South Korea tracker

Sponsor

Korea University Anam Hospital

Phase

Observational

Started

2023-03-09

Last updated

2024-04-04

Condition(s) studied

Diabetes MellitusCoronary Artery Disease

Investigational drug(s) / intervention(s)

Cre8™/Cre8™ EVO drug-eluting stent

Cre8™/Cre8™ EVO drug-eluting stent: Patient with CAD who undergoing PCI with Cre8™/Cre8™ EVO drug-eluting stent

Study 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

Sex

ALL

Min age

19 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Target lesion failure(Device-oriented composite endpoints) — 12 month
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

Trial sites (1)

Facility	City	Region	Status
Korea University Anam Hospital	Seoul	South Korea	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05759676 on ClinicalTrials.gov ↗ ← All trials in South Korea