The purpose of this study is to determine if the EKOS EkoSonic® Endovascular Device when used in conjunction with recombinant tissue plasminogen activator (t-PA) as a treatment for acute PE will decrease the ratio of right ventricle (RV) to left ventricle (LV) diameter within 48 =/- 6 hours in participants with massive or submassive PE.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Participants will receive 24 mg of r-tPA delivered via the EkoSonic Endovascular Device.
24 mg of r-tPA will be delivered through the EkoSonic Endovascular System.
Baptist Health
Montgomery, Alabama, United States
Memorial Medical Center
Modesto, California, United States
Stanford University Medical Center
Stanford, California, United States
Hartford Hospital
Hartford, Connecticut, United States
Christiana Hospital
Newark, Delaware, United States
Lakeland Regional Medical Center
Lakeland, Florida, United States
Holmes Regional Medical Center
Melbourne, Florida, United States
Florida Hospital
Orlando, Florida, United States
Orlando Regional Medical Center
Orlando, Florida, United States
Medical Center of Central Georgia
Macon, Georgia, United States
...and 12 more locations
Change From Baseline in the Right Ventricle (RV) Diameter-to-Left Ventricle (LV) Diameter Ratio Within 48 +/- 6 Hours of Initiation of Therapy
Change from baseline in RV diameter/LV diameter ratio was determined by contrast-enhanced chest computed tomography (CT) within 48 +/- 6 hours after initiating ultrasound-accelerated catheter-directed fibrinolysis.
Time frame: Baseline, within 48 +/- 6 hours of initiation of therapy
Number of Participants With Major Bleeding
Bleeding adverse events were graded (severe or life-threatening, moderate or mild bleeding) according to the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) classification. The participant incidence of major bleeding events was defined as GUSTO moderate and severe events occurring within 72 hours after starting the ultrasound-accelerated catheter-directed fibrinolysis procedure. Mild: Does not meet criteria for moderate or severe; Moderate: Requires transfusion - No hemodynamic compromise; and Severe: Bleeding causes hemodynamic compromise and required intervention or intracranial hemorrhage. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Time frame: From start of study drug infusion up to 72 hours
Change From Baseline in Pulmonary Artery Systolic Pressure at 48 Hours After Start of Therapy
Change in pulmonary artery systolic pressure was assessed by baseline right-heart catheterization compared with right-heart catheterization at the conclusion of ultrasound-accelerated catheter-directed fibrinolysis and estimated by post-procedure transthoracic echocardiography within 48 hours after initiating the procedure.
Time frame: Baseline, Hour 48 after initiation of therapy
Percentage of Participants With Symptomatic Recurrent Pulmonary Embolism (PE)
Percentage of participants with symptomatic recurrent PE up to 30 days following the conclusion of the ultrasound-accelerated catheter-directed fibrinolysis procedure, were reported with a Wilson score 95% confidence interval. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Time frame: Baseline up to Day 30
Number of Participants Who Died Due to Any Cause
Number of participants who died due to any cause for up to 30 days following the conclusion of the ultrasound-accelerated catheter-directed fibrinolysis procedure, were reported.
Time frame: Baseline up to Day 30
Number of Devices That Could Not be Successfully Used for Infusion
Technical complications associated with the use of the EkoSonic device was recorded during catheter placement in the pulmonary artery and during the infusion procedure.
Time frame: Baseline up to Day 30
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