This study 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 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
10
Use of Vertex Pulmonary Embolectomy System to treat pulmonary embolism.
AKH Vienna - Medical university of Vienna
Vienna, Austria
Jagiellonian University
Krakow, Poland
Change in Right Ventricle/Left Ventricle (RV/LV) Ratio
The RV/LV diameter ratio is defined as the ratio of the maximal right ventricle (RV) to left ventricle (LV) diameters measured on computed tomography (CT) pulmonary angiography images. Measurements are performed by an independent core laboratory using standardized axial CT images, with ventricular diameters measured at the widest point of each ventricle. Change in RV/LV ratio is calculated for each participant as the difference between the value obtained at baseline (pre-procedure) and the value obtained at 48 hours post-procedure or at hospital discharge, whichever occurs first. A reduction in RV/LV ratio indicates improvement in right ventricular dilatation.
Time frame: From baseline to 48 hours or discharge
Major Adverse Events (MAEs)
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
Time frame: Within 48 hours of procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.