This study is a prospective, single-arm, interventional, multicenter study to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the Akura Thrombectomy System in subjects with acute pulmonary embolism (PE).
The patient is 18 years of age or older and deemed medically eligible for interventional procedure, per institutional guidelines and clinical judgement
Clinical signs, symptoms and presentation consistent with acute PE
PE symptom duration ≤ 14 days
CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery)
Prior PE <180 days from index procedure
Thrombolytic use within 30 days prior to baseline CTA
Pulmonary hypertension with peak pulmonary arterial pressure (PAP) > 70 mmHg by right heart catheterization
Vasopressor requirement after fluids to keep pressure at ≥ 90 mmHg
Single group
ATC
DeviceThe ATC System is designed to mechanically remove emboli and restore blood flow through the pulmonary arteries in patients experiencing acute P
Effectiveness
Change in RV/LV ratio from baseline
Safety: Composite of Major Adverse Device-Related Events
Device-related major bleeding at access, device-related death, clinical deterioration, pulmonary vascular injury or cardiac injury
Safety: Composite of Major Adverse Events
Assessment of major adverse events through 30 day follow-up
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