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