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

ConditionsDiabetes MellitusCoronary Artery Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorKorea University Anam Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Patient with coronary artery disease who is undergoing percutaneous coronary intervention

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Cre8™/Cre8™ EVO drug-eluting stent

    Device

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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

Incidence of all-cause mortality

Incidence of all-cause mortality in patient with DM and non-DM

Time frame
12 month
3

Incidence of all-cause cardiac death

Incidence of all-cause cardiac death in patient with DM and non-DM

Time frame
12 month
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Korea University Anam Hospital

Lead sponsor

Diomedical

Collaborator

Source ClinicalTrials.gov
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