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%;
Vicora, Inc.
Lead sponsor
KCRI
Collaborator