Randomized Controlled Trial of High-Risk Pulmonary Embolism Comparing FlowTriever System vs. Standard of Care
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Mechanical thrombectomy for pulmonary embolism
Standard of care treatment for pulmonary embolism
Yale University
New Haven, Connecticut, United States
Composite clinical endpoint of the following adjudicated events:
1. All-cause mortality 2. Cardiac arrest 3. Bailout to an alternative therapeutic strategy 4. Major bleeding 5. ECMO life support
Time frame: The earlier of initial hospital discharge or 7 days after randomization
All-cause mortality
Time frame: At the earlier of initial hospital discharge or 7 days post randomization and at 3-month visit
Cardiac arrest
Time frame: At the earlier of initial hospital discharge or 7 days post randomization
Bailout to an alternative therapeutic strategy
Time frame: At the earlier of initial hospital discharge or 7 days post randomization
Major bleeding
Time frame: At the earlier of initial hospital discharge or 7 days post randomization and at 3-month visit
ECMO life support
Time frame: 7 days post-randomization
PE-related mortality
Time frame: 3 months
All-cause and PE-related readmissions
Time frame: 30 days and 90 days
Days alive outside hospital
Time frame: 90 days
PE-related quality of life, by PEmb-QoL
Time frame: 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Orlando Health Regional Medical Center
Orlando, Florida, United States
RECRUITINGSarasota Memorial Hospital
Sarasota, Florida, United States
RECRUITINGEmory University
Atlanta, Georgia, United States
RECRUITINGUniversity of Mississippi Medical Center
Jackson, Mississippi, United States
RECRUITINGNorthwell Health
Bay Shore, New York, United States
RECRUITINGSUNY, The University at Buffalo
Buffalo, New York, United States
RECRUITINGUPHS Penn Health System
Philadelphia, Pennsylvania, United States
RECRUITINGAllegheny General Hospital
Pittsburgh, Pennsylvania, United States
RECRUITINGHCA Tristar/Centennial
Nashville, Tennessee, United States
RECRUITING...and 15 more locations
General health-related quality of life, by EQ-5D-5L
Time frame: 3 months
Post-PE Impairment diagnosis
Time frame: 3 months
Change in the RV/LV diastolic diameter ratio (RV/LV) as measured by echocardiography from baseline
Time frame: 72 hours