Treatment for Pulmonary Embolism
Protocol: STUDY00006005
Full Title
This study is enrolling patients diagnosed with a pulmonary embolism (PE), or a blood clot trapped in the lung. The goal of the study is to compare two treatments for PE: (1) the FlowTriever Retrieval/Aspiration System (referred to as “FlowTriever”) which removes the clot by pulling it into a catheter (a flexible plastic tube) and (2) using catheter directed thrombolysis (“CDT”) devices which are placed close to the PE and slowly release a medication to dissolve the clot.

Participants will be randomly assigned to a study group (either FlowTriever or CDT) by chance, like flipping a coin. Information will be collected before, during and after the PE treatment procedure. This information will include physical exams, medications for anticoagulation (blood thinners), examination of surgery access site , laboratory results, quality of life assessments, and CT (X-ray) and/or echocardiography (a procedure that uses sound to look at the heart) imaging. The study schedule includes the following: baseline evaluation (up to 72 hours prior to treatment); study procedure; and evaluations at 24 hours after procedure, at hospital discharge, and 30 days after procedure.
Compensation: No
1. Age 18 years or older 2. Echo, compute tomographic pulmonary angiography (CTPA), or pulmonary angiographic evidence of any proximal filing defect in at least one main or lobar pulmonary artery. 3. Classification of intermediate-high-risk PE by ESC Guidlines 2019, including ALL of the following: a. Clinical signs and symptoms consistent with acute PE, or PESI class III-V, or sPESI >/=1 b. Hemodynamically stable AND c. RV dysfunction on echocardiography or CT AND d. Elevated cardiac troponin levels 4. Intervention planned to begin within 72 hours of the later of either a. Confirmed PE diagnosis OR b. If transferring from another hospital, arrival at the treating hospital 5. Symptom onset within 14 days of confirmed PE diagnosis
Age Group: Adults
Principal Investigator: DAVID ZLOTNICK Open Study
+1 716-829-6115
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