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Набор по приглашению NCT06168305

Safety and Effectiveness of GENOSS® DES in Patients With Multivessel Coronary Artery Disease

— Наблюдательное Percutaneous Coronary Intervention Multivessel 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: GENOSS® DES Sirolimus Eluting Coronary Stent System.
Кому может быть актуально
Состояния в реестре: Percutaneous Coronary Intervention, Multivessel 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

Safety and Effectiveness of GENOSS® DES (Sirolimus-eluting Coronary Stent System) in Patients With Multivessel Coronary Artery Disease (MVCAD): A Multicenter, Prospective, Observational Study

Обзор

The investigators intend to establish a multicenter prospective observational study by enrolling and tracking patients with multivessel coronary artery disease (MVCAD) using Genoss DES, a device manufactured with pure domestic technology. The study aims to evaluate the efficacy and safety of Genoss DES in MVCAD patients.

Подробное описание

This study is a sponsor-driven clinical trial (SIT) that aims to enroll patients who have undergone treatment for multivessel coronary artery disease using Genoss stents. The study involves collecting data on the clinical and surgical processes of patients and tracking the occurrence of clinical events.

This prospective, multicenter observational study registers patients with acute coronary artery disease who have been treated with GENOSS stents at a total of 8 institutions.

As it is an observational study, the number of subjects is not separately calculated, but the plan is to recruit a total of 1,000 participants during the study registration period.

Вмешательства

  • Устройство GENOSS® DES Sirolimus Eluting Coronary Stent System
    The GENOSS® DES is L-605 cobalt chromium (CoCr) platform with a strut thickness of 70µm Sirolimus drug with concentration of 1.15µg/mm2 Abluminal biodegradable PLA and PLGA polymers.

Первичные конечные точки

  • Target Lesion Failure (TLF) [Срок оценки: at 12 months after the procedure]
Вторичные конечные точки (10)
  • Major adverse cardiac events (MACE) [Срок оценки: at 12 months after the procedure]
  • Cardiac death [Срок оценки: at 12 months after the procedure]
  • Non-cardiac death [Срок оценки: at 12 months after the procedure]
  • TV-MI (target vessel-myocardial infarction) [Срок оценки: at 12 months after the procedure]
  • Non-target vessel myocardial infarction [Срок оценки: at 12 months after the procedure]
  • ID-TVR (ischemia-driven target vessel revascularization) [Срок оценки: at 12 months after the procedure]
  • Non-ischemia driven target vessel revascularization [Срок оценки: at 12 months after the procedure]
  • Incidence rate of acute stent thrombosis within 24 hours, subacute stent thrombosis within 30 days, and late stent thrombosis at 1 year [Срок оценки: within 24 hours, 30 days, 1 year]
  • Device success [Срок оценки: during the procedure]
  • Procedure success [Срок оценки: during the hospitalization period (up to 3 days)]

Критерии участия

<Inclusion Criteria>

  • Adults over 19 years of age
  • Subjects with multivessel coronary artery disease (MVCAD) (However, subject registration is possible even if the treatment area is restenosis or recurrent lesion, including new lesions)
  • Subjects who underwent percutaneous coronary intervention (PCI) with GENOSS® DES
  • Research subjects who agree to the research protocol and clinical follow-up plan, voluntarily decide to participate in this clinical study, and give written consent in the informed consent form.

(However, in the case of foreigners, only those who can speak Korean fluently and understand Korean documents such as the consent form are included.)

<Exclusion Criteria>

  • Test subjects with known hypersensitivity or contraindications to the following drugs or substances: heparin, aspirin, clopidogrel, sirolimus, contrast medium (however, even subjects with hypersensitivity to contrast medium can be controlled by steroids and pheniramine) In this case, registration is possible, but if there is known anaphylaxis, it is excluded)
  • When balloon angioplasty is performed on a stenotic area, the balloon cannot be expanded.
  • Those whose remaining life expectancy is less than 1 year
  • Expecting to become pregnant, pregnant or lactating woman
  • The patient was admitted to the hospital due to cardiogenic shock and was predicted to have a low chance of survival based on medical judgment.

Subject

  • If the researcher determines that the product is not suitable for this clinical study or may increase the risks associated with participation in the study.
  • Foreigners who cannot speak Korean fluently and have difficulty understanding Korean documents

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

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

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

Идентификаторы

NCT: NCT06168305 · 2023GR0399

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗