Menu
Recruiting NCT05759676

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

— Observational Diabetes Mellitus Coronary Artery Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cre8™/Cre8™ EVO drug-eluting stent.
Who it may be relevant to
Registry conditions: Diabetes Mellitus, Coronary Artery Disease. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

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

Primary outcome measures

  • Target lesion failure(Device-oriented composite endpoints) [Time frame: 12 month]
Secondary outcome measures (11)
  • patient-oriented composite endpoint [Time frame: 12 month]
  • Incidence of all-cause mortality [Time frame: 12 month]
  • Incidence of all-cause cardiac death [Time frame: 12 month]
  • Incidence of all-cause non-cardiac death [Time frame: 12 month]
  • Incidence of any myocardial infarction [Time frame: 12 month]
  • Incidence of any myocardial infarction not clearly attributatble to a non-target vessel [Time frame: 12 month]
  • Incidence of any revascularization [Time frame: 12 month]
  • Incidence of target lesion revascularization [Time frame: 12 month]
  • Incidence of stent thrombosis [Time frame: 12 month]
  • Lesion success rate [Time frame: the day of procedure]
  • Procedural success rate [Time frame: 1 month]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

South Korea · 1 center
  • Korea University Anam Hospital — Seoul

Identifiers

NCT: NCT05759676 · CRE8DM

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗