Efficacy and Safety of Short Duration of DAPT After GENOSS® DES Implantation in Patients with 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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Percutaneous Coronary Intervention, Dual Antiplatelet Therapy. 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 to Evaluate the Efficacy and Safety of Short Duration of DAPT After GENOSS® DES Implantation in Patients with Coronary Artery Disease
Обзор
The objective of study is to evaluate the efficacy and safety of short duration of DAPT after GENOSS® DES Implantation in patients with coronary artery disease.
Подробное описание
The Genoss DES is a novel, biodegradable, polymer-coated, sirolimus eluting stent with a cobalt-chromium stent platform and thin strut. Although the efficacy and safety of this stent have been previously investigated, real-world clinical outcomes data are lacking. Therefore, the objective of this prospective, multicenter study was to evaluate the clinical efficacy and safety of short duration of DAPT after GENOSS® DES Implantation in patients with coronary artery disease.
The Genoss DES registry is a prospective, single-arm, observational study for evaluation of clinical outcomes of short duration of DAPT (3 months for SCAD, 6 months for ACS) after Genoss DES implantation in patients with coronary artery disease from 6 sites in South Korea. The primary endpoint was a device-oriented composite endpoint (DOCE), defined as a composite of cardiac death, target vessel-related myocardial infarction (MI), and clinically indicated target lesion revascularization (TLR) at 12 months. The key secondary endpoint was a patient-oriented composite endpoint (POCE), defined as a composite of all-cause death, any myocardial infarction, and any revascularization at 12 months.
Первичные конечные точки
- Device-oriented composite endpoint [Срок оценки: at 12 months after the procedure]
Вторичные конечные точки (11)
- Patient-oriented composite endpoint [Срок оценки: at 12 months after the procedure]
- All-cause deaths [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]
- Any myocardial infarction [Срок оценки: at 12 months after the procedure]
- Target vessel-realted myocardial infarction (TV-MI) [Срок оценки: at 12 months after the procedure]
- Any revascularization [Срок оценки: at 12 months after the procedure]
- Clinically indicated target lesion revascularization (TLR) [Срок оценки: at 12 months after the procedure]
- Stent thrombosis by ARC definition [Срок оценки: at 12 months after the procedure]
- Lesion success [Срок оценки: during the procedure]
- Procedure success [Срок оценки: immediately after the procedure]
Критерии участия
Критерии включения
- Patients of 19 and over
- Patients with coronary artery disease treated with GENOSS SES
- Participants who voluntarily decide to participate in this clinical trial, agree to the study protocol and clinical follow-up plan, and provide written informed consent as study participants
Критерии исключения
- Patients with cardiogenic shock at the time of hospitalization
- Patients who are pregnant or planning to become pregnant
- Patients with a life expectancy of less than 1 year
- Patients participating in randomized controlled trials using other medical devices
- Patients who have already received treatment with another DES (Drug Eluting Stent) or BMS (Bare Metal Stent) at the time of registration (However, other stent insertions are allowed due to failure of GENOSS DES insertion)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Только случаи
Центры проведения
South Korea · 1 центр
- Wonju Severance Christian Hospital — Wŏnju
Идентификаторы
NCT: NCT06075420 · CIP-DS0501-13