Clinical trial NCT05759676: Efficacy and Safety of Polymer-free Amphilimus-eluting Stent According to the Diabetes
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus
Coronary Artery Disease
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
Collaborators: name: Diomedical
First posted: 2023-03-08
Enrollment: 1800
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with coronary artery disease who is undergoing percutaneous coronary intervention

Brief 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.


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

Primary outcomes:
measure: Target lesion failure(Device-oriented composite endpoints)
timeFrame: 12 month
Secondary outcomes:
measure: patient-oriented composite endpoint
timeFrame: 12 month
measure: Incidence of all-cause mortality
timeFrame: 12 month
measure: Incidence of all-cause cardiac death
timeFrame: 12 month
measure: Incidence of all-cause non-cardiac death
timeFrame: 12 month
measure: Incidence of any myocardial infarction
timeFrame: 12 month
measure: Incidence of any myocardial infarction not clearly attributatble to a non-target vessel
timeFrame: 12 month
measure: Incidence of any revascularization
timeFrame: 12 month
measure: Incidence of target lesion revascularization
timeFrame: 12 month
measure: Incidence of stent thrombosis
timeFrame: 12 month
measure: Lesion success rate
timeFrame: the day of procedure
measure: Procedural success rate
timeFrame: 1 month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
References: