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Идёт набор NCT05759676

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

— Наблюдательное Diabetes Mellitus Coronary Artery Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Cre8™/Cre8™ EVO drug-eluting stent.
Кому может быть актуально
Состояния в реестре: Diabetes Mellitus, Coronary Artery Disease. Базовые параметры: от 19 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
South Korea
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

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

Идентификаторы

NCT: NCT05759676 · CRE8DM

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗