Evaluating a new stent for diabetic patients with coronary artery disease
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
Korea University Anam Hospital · NCT05759676
This study is testing a new type of stent for people with diabetes who have heart artery problems to see if it works better and is safer than traditional stents.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1800 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Korea University Anam Hospital (other) |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05759676 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 19 or older with diabetes who require coronary angioplasty and have consented to participate.
Not a fit: Patients with known hypersensitivity to the stent materials or those who are pregnant or planning surgery that would require stopping antiplatelet drugs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes for diabetic patients with coronary artery disease by reducing complications associated with stent placement.
How similar studies have performed: Previous studies have shown promising results for the Cre8Evo stent in diabetic patients, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- Korea University Anam Hospital — Seoul, South Korea (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetes Mellitus, Coronary Artery Disease