Augmented Ultrasound-Facilitated, Catheter-Directed Fibrinolysis for PE

Paused

Conditions studied: Pulmonary Embolism, Right Ventricular Dysfunction, Right Ventricular Failure

In brief

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+™ 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.

Key facts

Study ID

NCT06310018

Run by

Brigham and Women's Hospital

People needed

60

Starts

2027-01-01

Expected to finish

2028-12-31

Last updated by the study team

2026-01-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• need for mechanical ventilation, including non-invasive positive pressure ventilation
• hematocrit <30%, platelet count <100,000/μl
• international normalized ratio >3
• serum creatinine > 2 mg/dL
• liver cirrhosis
• known hypersensitivity to tPA, heparin, or any excipients
• perceived high risk for fatal or catastrophic bleeding
• prescription of dual antiplatelet therapy (DAPT) at time of screening
• Patients treated with any other advanced therapy, such as surgical embolectomy, catheter-based mechanical embolectomy, or fibrinolytic therapy, within the prior 30 days
• pregnancy or lactation

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.