Evaluating the Efficacy, Safety and Long Term Functional Outcomes of Percutaneous Mechanical Aspiration Thrombectomy for Treatment of Acute Pulmonary Embolism Using the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System

Официальное название

Prospective, Multicenter, Multi-national, Single Arm Trial Evaluating the Efficacy, Safety and Long Term Functional Outcomes of Percutaneous Mechanical Aspiration Thrombectomy for Treatment of Acute Pulmonary Embolism Using the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System

Обзор

To evaluate the efficacy, safety, and long-term functional outcomes of percutaneous mechanical aspiration thrombectomy using the AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System for the treatment of acute pulmonary embolism.

Вмешательства

• Устройство AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
  Single Arm Study - Use of AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 for the treatment of acute pulmonary embolism

Первичные конечные точки

• Reduction in RV/LV ratio [Срок оценки: 48 hours]
• Incidence of Adverse Events [Safety and Tolerability] [Срок оценки: 12 months]

Вторичные конечные точки (12)

• Reduction in clot burden [Срок оценки: 48 hours]
• Use of thrombolytics [Срок оценки: 48 hours]
• Change in Biomarkers [Срок оценки: 48 hours]
• Composite Major Adverse Events [Срок оценки: 7 days]
• Individual Major Adverse Events [Срок оценки: 7 days]
• Days in ITU [Срок оценки: 7 days]
• All-cause mortality [Срок оценки: 30 days]
• PE-related mortality [Срок оценки: 30 days]
• Device-related Serious Adverse Events [Срок оценки: 30 days]
• Days In-patient [Срок оценки: 30 days]
• Hospital readmission [Срок оценки: 30 days]
• Symptom burden exercise test [Срок оценки: 30 days]

Критерии участия

Критерии включения

• Symptomatic, CTPA-proven acute PE with a maximum duration of symptoms of 14 days, showing a filling defect in at least one main or proximal lobar pulmonary artery
• RV/LV diameter ratio ≥ 1.0 assessed by CTPA
• Serum troponin levels above upper limit of normal as per hospital policy
• ≥ 18 years of age
• At least one of the following:

• Electrocardiogram (ECG)-documented tachycardia with heart rate ≥ 100 BPM, not due to hypovolemia, arrhythmia or sepsis
• Systolic blood pressure ≤ 110mmHg for at least 15 minutes
• Respiratory rate > 20 breaths per minuted. Oxygen saturation on pulse oximetry (SpO2) < 90% (or partial arterial oxygen pressure < 60 mmHg) at rest while breathing room air
• Known history of heart failure
• Willing and able to provide written informed consent prior to receiving study specific procedures.

Критерии исключения

• A contraindication to therapeutic anticoagulation
• Any comorbid diagnosis consistent with a life expectancy of less than 1 year (e.g., stage 4 cancer)
• Known serious, uncontrolled sensitivity to radiographic agents
• Cardiac arrest within last 14 days without documented evidence of recovery of conscious level to Glasgow Coma Scale >12
• Indication for ECMO
• Pregnant or breastfeeding
• Participation in another investigational drug or device study that study may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies.
• Other medical, social, or psychological conditions that, in the opinion of the Investigator, precludes the patient from appropriate consent, 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.
• History of congenital or acquired bleeding disorder predisposing to hemorrhagic state
• Platelet count < 100,000/μL
• Any advanced reperfusion therapy for pulmonary embolism within 30 days of the index procedure (e.g lysis, surgery, catheter intervention)
• A known clot in transit
• IVC filter
• A do not resuscitate limitation at inclusion in the study
• Deprived of liberty or under court protection

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

Польша · 1 центр

• Poznan University of Medical Sciences — Poznan

Идентификаторы

NCT: NCT06697314 · 2024-EVT-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗