Augmented Ultrasound-Facilitated, Catheter-Directed Fibrinolysis for PE

NCT06310018 | Suspended DMC FDA Drug FDA Device

• 1 other identifier: 2023A070902
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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+™ 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.

Conditions

Pulmonary Embolism; Right Ventricular Dysfunction; Right Ventricular Failure

Keywords

pulmonary embolism; right ventricular failure; right ventricular dysfunction; catheter-directed therapy; fibrinolysis

Outcome Measures

Primary Outcomes (2)

• Change in RV-to-LV diameter ratio as measured by chest CT from baseline to 48 ± 6 hours

  Change in RV-to-LV ratio will be determined by a dedicated core imaging laboratory, blinded to clinical data and timing of the CT studies

  48 ± 6 hours

• Frequency of ISTH major bleeding at 72 hours

  Adjudicated independently using ISTH criteria

  72 hours

Secondary Outcomes (2)

• Change in chest CT-measured blood volume in the distal pulmonary vasculature from baseline to 48 ± 6 hours

  48 ± 6 hours

• Change in refined Modified Miller Score as measured by chest CT from baseline to 48 ± 6 hours as measured by chest CT from baseline to 48 ± 6 hours

  48 ± 6 hours

Study Arms (1)

Ultrasound-facilitated, catheter-directed lower-dose fibrinolysis

10 patients with bilateral PE will be 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

Device: Ultrasound-facilitated, catheter-directed lower-dose fibrinolysis; Drug: Tissue Plasminogen Activator

Interventions

Ultrasound-facilitated, catheter-directed lower-dose fibrinolysis DEVICE

Ultrasound-facilitated, catheter-directed lower-dose fibrinolysis (treated with a total dose 8 mg tPA given as 2 mg/hour/catheter over 2 hours for first 10 patients followed by 50 patients treated with total dose 6 mg tPA given as 3 mg/hour/catheter given over 1 hour) with the EKOS+™ system

Ultrasound-facilitated, catheter-directed lower-dose fibrinolysis

Tissue Plasminogen Activator DRUG

total dose 8 mg tPA given as 2 mg/hour/catheter over 2 hours for first 10 patients followed by 50 patients treated with total dose 6 mg tPA given as 3 mg/hour/catheter given over 1 hour

Ultrasound-facilitated, catheter-directed lower-dose fibrinolysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who present for evaluation and treatment of PE and in whom the decision to proceed with the EKOS+™ ultrasound-facilitated, catheter-directed lower-dose fibrinolytic procedure will be screened for inclusion in the study.

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (5)

• Konstantinides SV, Meyer G, Becattini C, Bueno H, Geersing GJ, Harjola VP, Huisman MV, Humbert M, Jennings CS, Jimenez D, Kucher N, Lang IM, Lankeit M, Lorusso R, Mazzolai L, Meneveau N, Ni Ainle F, Prandoni P, Pruszczyk P, Righini M, Torbicki A, Van Belle E, Zamorano JL; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS). Eur Heart J. 2020 Jan 21;41(4):543-603. doi: 10.1093/eurheartj/ehz405. No abstract available.

  PMID: 31504429 BACKGROUND

• Hassan SM, Nardelli P, Minhas JK, Ash SY, Estepar RSJ, Antkowiak MC, Badlam JB, Piazza G, Estepar RSJ, Washko GR, Rahaghi FN. CT imaging determinants of persistent hypoxemia in acute intermediate-risk pulmonary embolism. J Thromb Thrombolysis. 2023 Jul;56(1):196-201. doi: 10.1007/s11239-023-02813-x. Epub 2023 May 4.

  PMID: 37140805 BACKGROUND

• Klok FA, Piazza G, Sharp ASP, Ni Ainle F, Jaff MR, Chauhan N, Patel B, Barco S, Goldhaber SZ, Kucher N, Lang IM, Schmidtmann I, Sterling KM, Becker D, Martin N, Rosenfield K, Konstantinides SV. Ultrasound-facilitated, catheter-directed thrombolysis vs anticoagulation alone for acute intermediate-high-risk pulmonary embolism: Rationale and design of the HI-PEITHO study. Am Heart J. 2022 Sep;251:43-53. doi: 10.1016/j.ahj.2022.05.011. Epub 2022 May 16.

  PMID: 35588898 BACKGROUND

• Piazza G. Advanced Management of Intermediate- and High-Risk Pulmonary Embolism: JACC Focus Seminar. J Am Coll Cardiol. 2020 Nov 3;76(18):2117-2127. doi: 10.1016/j.jacc.2020.05.028.

  PMID: 33121720 BACKGROUND

• Rahaghi FN, San Jose Estepar R, Goldhaber SZ, Minhas JK, Nardelli P, Vegas Sanchez-Ferrero G, De La Bruere I, Hassan SM, Mason S, Ash SY, Come CE, Washko GR, Piazza G. Quantification and Significance of Pulmonary Vascular Volume in Predicting Response to Ultrasound-Facilitated, Catheter-Directed Fibrinolysis in Acute Pulmonary Embolism (SEATTLE-3D). Circ Cardiovasc Imaging. 2019 Dec;12(12):e009903. doi: 10.1161/CIRCIMAGING.119.009903. Epub 2019 Dec 17. No abstract available.

  PMID: 31842589 BACKGROUND

MeSH Terms

Conditions

Pulmonary Embolism; Ventricular Dysfunction, Right; Heart Failure

Interventions

Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Ventricular Dysfunction; Heart Diseases

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Study Officials

• Gregory Piazza, MD, MS

  BWH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 13, 2024
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

US (1)