This study is a prospective, single-arm, multicenter study to evaluate the safety and effectiveness of the Vertex Pulmonary Embolectomy System in participants presenting with clinical signs and symptoms of acute pulmonary embolism.
The study is a prospective, single-arm, multicenter study to evaluate the safety and effectiveness of the Vertex Pulmonary Embolectomy System in participants presenting with clinical signs and symptoms of acute pulmonary embolism. The Vertex Pulmonary Embolectomy System is intended for the non-surgical removal of emboli and thrombi from blood vessels as a means for treating pulmonary embolism.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
123
Use of Vertex Pulmonary Embolectomy System to treat pulmonary embolism.
Hartford Hospital
Hartford, Connecticut, United States
Reduction in Right ventricle (RV) / Left Ventricle (LV) ratio
Reduction in RV/LV ratio from baseline to 48 hours or discharge by (core lab assessed) CT angiography
Time frame: From baseline to 48 hours or discharge
Major Adverse Events, a composite of:
Device-related death within 48 hours of the procedure Major bleeding within 48 hours of the procedure Device-related AEs within 48 hours, including: * Clinical deterioration * Pulmonary vascular injury * Cardiac injury
Time frame: Within 48 hours of the procedure
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