Идёт набор NCT06654453

The Thrombus Aspiration During PCI After Thrombolysis in STEMI

Без фазы С лечением ST-segment Elevation Myocardial Infarction

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: Thrombectomy, Percutaneous Coronary Intervention.
Кому может быть актуально: Состояния в реестре: ST-segment Elevation Myocardial Infarction. Базовые параметры: от 18 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: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

The Thrombus Aspiration During Percutaneous Coronary Intervention After Thrombolysis in ST-elevation Myocardial Infarction

Обзор

The goal of this clinical trial is to determine whether thrombus aspiration combined with percutaneous coronary intervention (PCI) improves clinical outcomes in ST-segment elevation myocardial infarction (STEMI) patients with high thrombus burden post-thrombolysis, compared to PCI alone. The study population includes 3500 STEMI patients, confirmed by diagnosis, who are transferred to PCI centers after receiving thrombolysis and have no contraindications to thrombolysis.The main questions it aims to answer are: 1. Does thrombus aspiration reduce 30-day major adverse cardiovascular events (MACE), including cardiovascular death, recurrent myocardial infarction, stroke, or heart failure rehospitalization? 2. Can thrombus aspiration improve microcirculation and clinical outcomes for high thrombus burden patients after thrombolysis? Researchers will compare patients randomly assigned to receive thrombus aspiration combined with PCI versus those who receive PCI alone to evaluate the effects on reducing MACE and improving clinical recovery. Participants will: Undergo initial thrombolysis followed by transfer to PCI centers. Be randomly assigned in a 1:1 ratio to receive either thrombus aspiration combined with PCI or PCI alone. Be followed for 30 days post-treatment to assess MACE and other clinical outcomes.

Вмешательства

Процедура Thrombectomy
Manual thrombectomy followed by Percutaneous Coronary Intervention (PCI), a procedure involving mechanical removal of thrombus before stent placement in coronary arteries to restore blood flow in STEM
Процедура Percutaneous Coronary Intervention
Percutaneous Coronary Intervention, involving balloon angioplasty and stent placement to open blocked coronary arteries in STEMI patients after thrombolysis.

Первичные конечные точки

30-day Major Adverse Cardiovascular Events (MACE) [Срок оценки: From enrollment to the end of treatment at 4 weeks]

Вторичные конечные точки (5)

Reperfusion Success [Срок оценки: Within 30 minutes post-PCI (Percutaneous Coronary Intervention)]
Follow-up MACE at 6 Months [Срок оценки: From enrollment to the end of treatment at 6 months]
Follow-up all-cause mortality at 6 Months [Срок оценки: From enrollment to the end of treatment at 6 months]
Follow-up MACE at 12 Months [Срок оценки: From enrollment to the end of treatment at 12 months]
Follow-up all-cause mortality at 12 Months [Срок оценки: From enrollment to the end of treatment at 12 months]

Критерии участия

Критерии включения

Diagnosed with STEMI.
No contraindications for thrombolysis and has received thrombolytic treatment.
Undergoing coronary angiography within 2 to 24 hours post-thrombolysis.
Angiographic results confirm TIMI thrombus load ≥ 4 and residual stenosis > 50%.