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NCT Number: NCT05759676

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

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.

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Key information

Conditions

Diabetes Mellitus Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Korea University Anam Hospital

Seoul, 136-705, South Korea

Location status: Recruiting

Location contact

Soon Jun Hong, MD, PhD

CONTACT

[email protected]

+82-2-920-5625

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cre8™/Cre8™ EVO drug-eluting stent

Device

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

Primary outcomes

  1. Target lesion failure(Device-oriented composite endpoints)

    Time frame: 12 month

    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

Secondary outcomes

  1. patient-oriented composite endpoint

    Time frame: 12 month

    composite of all-cause mortality, any myocardial infarction, and any revascularization in patient with DM and non-DM

  2. Incidence of all-cause mortality

    Time frame: 12 month

    Incidence of all-cause mortality in patient with DM and non-DM

  3. Incidence of all-cause cardiac death

    Time frame: 12 month

    Incidence of all-cause cardiac death in patient with DM and non-DM

  4. Incidence of all-cause non-cardiac death

    Time frame: 12 month

    Incidence of all-cause non-cardiac death in patient with DM and non-DM

  5. Incidence of any myocardial infarction

    Time frame: 12 month

    Incidence of any myocardial infarction in patient with DM and non-DM

  6. Incidence of any myocardial infarction not clearly attributatble to a non-target vessel

    Time frame: 12 month

    Incidence of any myocardial infarction not clearly attributatble to a non-target vessel in patient with DM and non-DM

  7. Incidence of any revascularization

    Time frame: 12 month

    Incidence of any revascularization in patient with DM and non-DM

  8. Incidence of target lesion revascularization

    Time frame: 12 month

    Incidence of target lesion revascularization in patient with DM and non-DM

  9. Incidence of stent thrombosis

    Time frame: 12 month

    Incidence of stent thrombosis in patient with DM and non-DM

  10. Lesion success rate

    Time frame: the day of procedure

    less than 50% of residual stenosis after all procedure in patient with DM and non-DM

  11. Procedural success rate

    Time frame: 1 month

    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

Sponsors and collaborators

Lead sponsor

Korea University Anam Hospital

Other

Collaborators

  • Diomedical

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 8, 2023
Registry last updated
Apr 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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