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

Coronary Artery Disease Clinical Trial

Official title:

A Prospective, Multicenter Observational Study of Efficacy and Safety of Polymer-free Amphilimus-eluting Stent (Cre8™/Cre8™ EVO) in Patients With Coronary Artery Disease According to the Presence of Diabetes Mellitus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05759676
• Other study ID #: CRE8DM
• Status: Recruiting
• Start date: March 9, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Korea University Anam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1800
• Est. completion date: December 31, 2026
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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 ? 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 ? 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 ? Subjects participating in medical device randomization research ? Patients who underwent surgery using a stent other than Cre8™/Cre8™ EVO at the time of registration

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Korea University Anam Hospital	Diomedical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 month
Secondary	patient-oriented composite endpoint	composite of all-cause mortality, any myocardial infarction, and any revascularization in patient with DM and non-DM	12 month
Secondary	Incidence of all-cause mortality	Incidence of all-cause mortality in patient with DM and non-DM	12 month
Secondary	Incidence of all-cause cardiac death	Incidence of all-cause cardiac death in patient with DM and non-DM	12 month
Secondary	Incidence of all-cause non-cardiac death	Incidence of all-cause non-cardiac death in patient with DM and non-DM	12 month
Secondary	Incidence of any myocardial infarction	Incidence of any myocardial infarction in patient with DM and non-DM	12 month
Secondary	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	12 month
Secondary	Incidence of any revascularization	Incidence of any revascularization in patient with DM and non-DM	12 month
Secondary	Incidence of target lesion revascularization	Incidence of target lesion revascularization in patient with DM and non-DM	12 month
Secondary	Incidence of stent thrombosis	Incidence of stent thrombosis in patient with DM and non-DM	12 month
Secondary	Lesion success rate	less than 50% of residual stenosis after all procedure in patient with DM and non-DM	the day of procedure
Secondary	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	1 month