Evaluating a new stent for diabetic patients with coronary artery disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study assesses the efficacy and safety of the polymer-free Amphilimus-eluting Cre8Evo stent in patients with diabetes mellitus undergoing coronary angioplasty. The Cre8Evo stent is designed to minimize inflammatory responses and reduce the risk of stent thrombosis, offering potential advantages over traditional drug-eluting stents. The study aims to evaluate its performance in preventing late proliferation of vascular smooth muscle cells in diabetic patients compared to other stent options. Participants will be monitored for clinical outcomes following stent placement.

Why it matters

Who can join: the full rules

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

Where it's running

• Korea University Anam Hospital
  Seoul, South Korea Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.