Идёт набор NCT06152341

Safety and Effectiveness of the ATC System in the Treatment of Acute PE

Без фазы С лечением Pulmonary Embolism Acute

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: ATC System.
Кому может быть актуально: Состояния в реестре: Pulmonary Embolism Acute. Базовые параметры: 18 лет — 90 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: Бразилия, Dominican Republic
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 the ATC System in the Treatment of Acute Pulmonary Embolism

Обзор

This study is a prospective, single-arm, interventional, multicenter study to evaluate the safety and effectiveness of the ATC System in subjects with acute pulmonary embolism (PE).

Вмешательства

Устройство ATC System
The ATC System is designed to mechanically remove emboli and restore blood flow through the pulmonary arteries in patients experiencing acute PE

Первичные конечные точки

Effectiveness [Срок оценки: 48 hours post index procedure]
Safety: Composite of Major Adverse Device-Related Events [Срок оценки: 48 hours post index procedure]

Вторичные конечные точки (1)

Safety: Composite of Major Adverse Events [Срок оценки: 30 days post index procedure]

Критерии участия

Критерии включения

Patient is ≥ 18 and ≤ 90 years old
Clinical signs and symptoms consistent with acute PE for < 14 days
CTA evidence of proximal PE
RV/LV ratio > 0.9
Systolic BP ≥90 mmHg without the need for vasopressors
Stable heart rate (HR) < 130 BPM prior to procedure
Patient is deemed medically eligible for interventional procedure(s), per investigator guidelines and clinical judgment
Subject or legally authorized representative (LAR) is willing and able to provide written informed consent prior to receiving any non-standard of care protocol specific procedures

Критерии исключения

Prior PE < 180 days from index procedure
Thrombolytic use < 30 days prior to baseline CTA
Pulmonary hypertension with peak pulmonary artery systolic pressure (PASP) >70 mmHg by right heart catheterization
FiO2 requirement >40% or >6 LPM to keep oxygen saturation >90%
Hematocrit <28%
Platelets count <100,000/µL
Serum creatinine >1.8 mg/dL
International normalized ratio (INR) >3
Major trauma injury severity score (ISS) >15 prior to screening assessment
Presence of intracardiac lead in right ventricle or atrium placed within 6 months prior to screening assessment
Cardiovascular or pulmonary surgery within 7 days of index procedure
Actively progressing cancer treated by chemotherapeutics
Known bleeding diathesis or coagulation disorder
Left bundle branch block
History of severe or chronic pulmonary arterial hypertension
History of chronic left heart disease with left ventricular ejection fraction ≤ 30%
History of decompensated heart failure
History of underlying lung disease that is oxygen dependent
History of chest irradiation
History of heparin-induced thrombocytopenia (HIT)
Contraindication to systemic or therapeutic doses of anticoagulants
Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
Imaging evidence or other evidence that suggest, in the opinion of the investigator, the Subject is not appropriate for aspiration thrombectomy intervention
Life expectancy <90 days, as determined by investigator such as stage 4 cancer, frailty or severe COVID infections
Female who is pregnant or nursing
Current participation in another investigational drug or device treatment study.