Evaluation of the Magneto eTrieve™ PE Kit for Endovascular Thrombectomy in Subjects With Acute Pulmonary Embolism

Официальное название

Evaluation of the Safety and Effectiveness of Magneto eTrieve™ PE Kit for Endovascular Thrombectomy in Subjects With Acute Pulmonary Embolism

Обзор

Prospective, multi-center, open-label, single-arm clinical study of the safety and effectiveness of the eTrieve™ in subjects presenting with signs and symptoms of acute intermediate-risk pulmonary embolism

Вмешательства

• Устройство eTrieve PE Kit
  Patients will be treated with the eTrieve PE Kit

Первичные конечные точки

• MAE [Срок оценки: 48 hours]
• RV/LV ratio [Срок оценки: 48 hours]

Вторичные конечные точки (6)

• Use of thrombolytics [Срок оценки: within 48 hours]
• ICU/hospitalization length [Срок оценки: within 30 days]
• Modified Miller score [Срок оценки: at 48 hours]
• Mortality [Срок оценки: within 30 days]
• Device related SAE [Срок оценки: within 30 days]
• PE reocurrence [Срок оценки: within 30 days]

Критерии участия

Критерии включения

• Age ≥ 18 years
• Clinical signs, symptoms, and presentation consistent with acute pulmonary embolism (PE)
• PE symptom duration ≤ 14 days
• Filling defect in at least one main or lobar pulmonary artery on CTA
• Right ventricle / left ventricle (RV/LV) ratio ≥ 0.9 on CTA (Investigator's reading)
• Systolic blood pressure ≥ 90 mmHg
• Stable heart rate < 130 BPM prior to the index procedure
• Anatomy that, in the opinion of the interventionalist, allows safe passage of the eTrieve™ catheters
• Written informed consent

Критерии исключения

• Patients with a combined reason for their decompensation (e.g., a patient with both sepsis and PE)
• PE within 3 months prior to screening assessment
• Thrombolytic use within 30 days prior to baseline CTA
• Pulmonary hypertension with peak systolic PAP > 70 mmHg
• Inotrope or vasopressor requirement after fluid administration to keep the systolic blood pressure ≥ 90 mmHg
• Fraction of inspired Oxygen (FiO2) requirement > 40% or supplemental oxygen > 6 LPM to keep oxygen saturation > 90%
• Any of the following laboratory findings (within 6 hours prior to index procedure):

• Hematocrit < 28%
• Platelets < 100,000/µL
• Serum creatinine > 1.8 mg/dL
• INR > 3
• Major trauma Injury Severity Score (ISS) > 15 within 14 days prior to screening assessment
• Intracardiac lead in right ventricle, right atrium or coronary sinus, placed within 6 months prior to screening assessment
• Known presence of intracardiac clot
• Cardiovascular or pulmonary surgery within last 7 days
• Active malignancy and / or on chemotherapy
• Known bleeding diathesis or coagulation disorder
• Left bundle branch block
• History of severe or chronic pulmonary arterial hypertension
• History of left ventricular ejection fraction ≤ 30%
• History of decompensated heart failure
• History of underlying oxygen dependent lung disease
• History of chest irradiation
• History of Heparin Induced Thrombocytopenia (HIT)
• Any contraindication to systemic therapeutic doses of heparin or other anticoagulants
• Known anaphylactic reaction to radiographic contrast agents that cannot be adequately pre-medicated
• Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically
• Imaging evidence or other evidence that suggests, in the opinion of the investigator, the subject is not appropriate for mechanical thrombectomy intervention
• Life expectancy of < 90 days as determined by the investigator
• Co-morbid condition(s) that, in the opinion of the investigator, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study
• Female who is pregnant or nursing
• Current participation in another investigational drug or device treatment study
• Previous enrollment in the eTrieve™ II Study

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05821426 · KT1-CLN010

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗