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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Diabetes Mellitus
• Intervention / Treatment: Device: Cre8™/Cre8™ EVO drug-eluting stent

• Study Type: Observational
• Enrollment (Estimated): 1800

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 136-705
    • Recruiting
    • Korea University Anam Hospital
    • Contact: Soon Jun Hong, MD, PhD; Phone Number: +82-2-920-5625; Email: psyche94@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient with coronary artery disease who is undergoing percutaneous coronary intervention

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Korea University Anam Hospital
• Collaborators: Diomedical

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 26, 2023
• First Submitted That Met QC Criteria: February 26, 2023
• First Posted (Actual): March 8, 2023

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Endocrine System Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Diabetes Mellitus
• Other Study ID Numbers: CRE8DM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The subject identification information used in the study will be coded and managed so that personal identification is impossible. Documents and materials related to this study will be stored in a locked place designated by the research director. In accordance with Article 15 of the Enforcement Rules of the Bioethics and Safety Act, research-related records are planned to be kept for 3 years from the time the research is completed, and documents that have passed the retention period will be destroyed according to the relevant grounds.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No