Augmented Ultrasound-Facilitated, Catheter-Directed Fibrinolysis for PE (NCT06310018) | Clinical Trial Compass
SuspendedNot Applicable
Augmented Ultrasound-Facilitated, Catheter-Directed Fibrinolysis for PE
Stopped: Awaiting completion and reporting of related trial
United States60 participantsStarted 2027-01-01
Plain-language summary
SONIC-PE is a multicenter, prospective, single-arm study of 10 patients with bilateral PE treated with ultrasound-facilitated, catheter-directed lower-dose fibrinolysis (total dose 8 mg tPA given as 2 mg/hour/catheter over 2 hours) followed by 50 patients (total dose 6 mg tPA given as 3 mg/hour/catheter given over 1 hour) with the EKOS+â„¢ system to determine its impact on the change in RV-to-LV diameter, refined Modified Miller Score, and distal pulmonary vascular blood volume as well as to assess International Society on Thrombosis and Haemostasis (ISTH) major bleeding.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. patients at least 18 years of age,
✓. symptomatic PE defined as symptoms for \<14 days with normal systolic blood pressure (\>90 mmHg), RV-to-LV diameter ratio ≥0.9 on initial chest CT, bilateral filling defects located in at least 1 main or proximal lobar pulmonary artery, and cardiac troponin greater than the upper limit of normal (cTnI, cTnT, hsTnI, or hsTnT), AND
✓. in whom ultrasound-facilitated, catheter-directed lower-dose fibrinolysis has been selected for treatment on a clinical basis.
Exclusion criteria
✕. stroke or transient ischemic attack, head trauma, other active intracranial or intraspinal disease (including malignancy) within 1 year
✕. recent active bleeding from a major organ within 1 month
✕. major surgery within 7 days of screening
✕. contraindication to therapeutic anticoagulation
✕. systolic blood pressure \<90 mm Hg, systolic blood pressure drop by at least 40 mmHg over at least 15 minutes, shock, use of vasopressors, need for CPR, or need for ECMO
What they're measuring
1
Change in RV-to-LV diameter ratio as measured by chest CT from baseline to 48 ± 6 hours