A prospective, multicenter, randomized controlled trial of the FlowTriever System compared to Catheter-Directed Thrombolysis (CDT) for use in the treatment of acute pulmonary embolism. The trial includes a non-randomized cohort of subjects with an absolute contraindication to thrombolysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
692
Catheter-Directed Thrombolysis for pulmonary embolism (any commercially available CDT system)
Mechanical thrombectomy for pulmonary embolism
Primary Endpoint: Composite Clinical Endpoint Constructed as a 5-Component Win Ratio
The primary endpoint is a composite constructed as a hierarchical win ratio of the following 5 components: 1. All-cause mortality, or 2. Intracranial hemorrhage (ICH), or 3. Major bleeding per ISTH definition, or 4. Clinical deterioration defined by hemodynamic or respiratory worsening, and/or escalation to a bailout therapy, or 5. ICU admission and ICU length-of-stay during the index hospitalization and following the index procedure. A win ratio larger than 1 indicates that patients who receive treatment with FlowTriever are more likely to have better outcomes as compared to subjects treated with CDT.
Time frame: Hospital discharge or at 7 days after the index procedure, whichever is sooner
Composite Clinical Endpoint Constructed as a 4-Component Win Ratio
This secondary endpoint is a composite constructed as a hierarchical win ratio of the following 4 components: * All-cause mortality, or * Intracranial hemorrhage (ICH), or * Major bleeding per ISTH definition, or * Clinical deterioration defined by hemodynamic or respiratory worsening, and/or escalation to a bailout therapy A win ratio larger than 1 indicates that patients who receive treatment with FlowTriever are more likely to have better outcomes as compared to subjects treated with CDT.
Time frame: Hospital discharge or at 7 days after the index procedure, whichever is sooner
All-cause Mortality
Time frame: Hospital discharge or at 7 days after the index procedure, whichever is sooner
Intracranial Hemorrhage (ICH)
Time frame: Hospital discharge or at 7 days after the index procedure, whichever is sooner
Major Bleeding Per ISTH Definition
Time frame: Hospital discharge or at 7 days after the index procedure, whichever is sooner
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Tallahassee Memorial Hospital
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University of South Florida Tampa General Hospital
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
...and 50 more locations
Clinical Deterioration Defined by Hemodynamic or Respiratory Worsening, and/or Escalation to a Bailout Therapy
Clinical deterioration is defined as documented objective hemodynamic or respiratory worsening that is new (i.e. not present at the time of enrollment). Bailout therapy is an unplanned escalation of therapeutic measures, taken when the patient's condition has not improved or is not improving according to expectations.
Time frame: Hospital discharge or at 7 days after the index procedure, whichever is sooner
ICU Admission During the Index Hospitalization and Following the Index Procedure
Time frame: Hospital discharge or at 7 days after the index procedure, whichever is sooner
ICU Length of Stay During the Index Hospitalization and Following the Index Procedure Among Subjects With ICU Admission.
Time frame: Hospital discharge or at 7 days after the index procedure, whichever is sooner
All Cause Mortality
Time frame: 30 days from index procedure
All-cause and PE-related Readmissions
Time frame: 30 days from index procedure
Device-related Serious Adverse Events
Device-related SAEs included those adjudicated by the CEC to be related to the interventional device.
Time frame: Through the 30 day visit
Drug-related Serious Adverse Events
Drug-related SAEs included those adjudicated by the CEC to be related to anticoagulation and/or thrombolytics medication.
Time frame: Through the 30 day visit
Clinically Relevant Non-Major (CRNM) and Minor Bleeding Events
Time frame: Hospital discharge or at 7 days after the index procedure, whichever is sooner
Change in Right-ventricular/Left-ventricular (RV/LV) Ratio, as Measured by Echocardiography or CT
Assessments of change were made using the same imaging modality at baseline and at the 24-hour visit.
Time frame: Baseline to 24 hour visit
Modified Medical Research Council (mMRC) Dyspnea Score at 24 Hour Visit
The mMRC score is reported on a 0-4 scale with lower scores representing less dyspnea.
Time frame: At 24 hour visit
Modified Medical Research Council (mMRC) Dyspnea Score at 30 Day Visit
The mMRC score is reported on a 0-4 scale with lower scores representing less dyspnea.
Time frame: At 30 day visit
Length of Total Hospital Stay
Time frame: Through 30 days post-procedure
Length of Post-index-procedure Hospital Stay
Time frame: Through 30 days post-procedure
Pulmonary Embolism Quality of Life (PEmb-QOL) Score at 30 Day Visit
The Pulmonary Embolism Quality of Life (PEmb-QOL) questionnaire is used to assess the quality of life in patients with pulmonary embolism (PE). It is a disease-specific tool designed to evaluate the impact of PE on various aspects of a patient's life, including daily activities, work, social life, and emotional well-being, and is reported on a 0-100 scale with lower scores representing better quality of life.
Time frame: At 30 day visit
EQ-5D-5L Quality of Life Score at 30 Day Visit
Each of the five dimensions comprising the EQ-5D-5L descriptive system (mobility, self-care, usual activates, pain/discomfort, anxiety/depression) are graded from 1 (no problems) to 5 (extreme problems). A descriptive health state is defined by combining each level for 5 dimensions into a 5-digit code (e.g., 12345) which is then mapped to the health state index score based on a country-specific value set. Health state index scores range from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health).
Time frame: At 30 day visit