The study is a prospective, single-arm, multicenter study to evaluate the safety and effectiveness of the Vibrato™ Aspiration System for aspiration mechanical thrombectomy in the treatment of acute PE. This is the First in Man clinical study.
Age ≥ 18 and ≤ 75 years.
Clinical signs, symptoms, and presentation consistent with acute PE;
PE symptom duration ≤ 14 days;
CTA evidence (site determined) of proximal PE (filling defect in at least one main or interlobar pulmonary artery)
Thrombolytic use within 30 days of baseline CT angiogram
Pulmonary hypertension with peak pulmonary artery pressure > 70 mmHg by right heart catheterization (site determined)
Vasopressor requirement after fluids to keep pressure ≥ 90 mmHg;
FiO2 requirement > 40% or > 6 LPM to keep oxygen saturation > 90%;
Single group
Mechanical Thrombectomy
DeviceMechanical Thrombectomy for the treatment of Acute Pulmonary Embolism
Safety Endpoint: Major Adverse Events
Major Adverse Events, a composite of: * Device-related death within 48 hours * Major bleeding within 48 hours * Device-related AEs within 48 hours, including: * Clinical deterioration * Pulmonary vascular injury * Cardiac injury
Efficacy Endpoint: Reduction in RV/LV Ratio
Reduction in RV/LV ratio from baseline to 48 hours or discharge by CT angiography
Safety Endpoint: Device-Related Death
Device-related death within 48 hours
Safety Endpoint: Major Bleeding
Major bleeding within 48 hours
Safety Endpoint: Device-Related Clinical Deterioration
Device-related clinical deterioration within 48 hours
Safety Endpoint: Device-Related Pulmonary Vascular Injury
Device-related pulmonary vascular injury within 48 hours
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Vicora, Inc.
Lead sponsor
KCRI
Collaborator