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.
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
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
Single group
AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
DeviceSingle Arm Study - Use of AngioDynamics' AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 for the treatment of acute pulmonary embolism
Reduction in RV/LV ratio
Reduction in RV/LV ratio between baseline and 48 hours post-procedure assessed by paired computed tomography pulmonary angiography (CTPA)
Incidence of Adverse Events [Safety and Tolerability]
The primary safety endpoint is the incidence of adverse events by type and seriousness through 12 months. The number and proportion of subjects who experienced at least one adverse event will be summarized, and the 95% confidence interval of the proportion will be presented.
Reduction in clot burden
• Reduction in clot burden (measured by refined Modified Miller Index score) between baseline and 48 hours post-procedure assessed by paired CTPA
Use of thrombolytics
Use of thrombolytics within 48 hours of the index procedure
Change in Biomarkers
Change in troponin, BNP, and D-dimer from baseline to 48 hours post-procedure
Composite Major Adverse Events
* Composite Major Adverse Events within 7 days of the index procedure 1\) PE-related death/deterioration: * Death * Cardiac Arrest * Institution of new vasopressors * ECMO * Mechanical ventilation 2\) Device-related death/deterioration: * Death * BARC 3a/3b/3c/-5 Major Bleeding * Clinical Deterioration * Pulmonary Vascular Injury * Peripheral Vascular Injury * Cardiac Injury * Stroke
Cardiac MRI
• Cardiac MRI at 12-months post-procedure (for up to 100 patients) to assess: * RA/RV dimension and function * Signs of RV fibrosis * Pulmonary parenchymal function and abnormalities * Pulmonary vascular structure * Tricuspid regurgitation severity * Ventricular Septal motion characteristics
Peak Oxygen Consumption
• Peak Oxygen consumption (for up to 100 patients): PVO2 measured during cardiopulmonary exercise test at 12 months post-procedure
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