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Recruiting Observational

Ultrasound-assisted, Catheter-directed Thrombolysis for Acute Intermediate-high-risk Pulmonary Embolism

NCT06143969 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2022-11-28
Last updated
2026-04-16

Condition(s) studied

Pulmonary Embolism

Investigational drug(s) / intervention(s)

ultrasound-assisted, catheter-directed thrombolysis

ultrasound-assisted, catheter-directed thrombolysis: After 10 hours of alteplase infusion and EKOSTM ultrasound, the therapy is stopped, the EKOSTM catheter is removed, and the puncture site (internal jugular vein or femoral vein) has to be compressed.

Study summary

The purpose of this retrospective and prospective multicenter study is to evaluate the incidence of pulmonary hypertension (PH) within 6 months from ultrasound-assisted, Catheter-directed Thrombolysis for acute intermediate- high-risk Pulmonary Embolism

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria * Patients admitted with acute intermediate-high risk PE, defined according to ESC guidelines * Symptoms onset within previous 14 days associated or not with deep venous thrombosis * Confirmation of the PE by contrast-enhanced computed tomography of the chest with embolus located in at least one main or proximal lower lobe pulmonary artery * Echocardiographic parameters of RV disfunction * Patients with high-risk PE or hemodynamic deterioration on anticoagulation, who have absolute contraindications (high bleeding risk) to systemic thrombolysis and symptoms onset during the last 14 days. Patients with surgery-related embolic complications are also included (within 48 hours). Exclusion Criteria * Age \< 18 years old * Patients unable to give informed consent * Pregnancy * Patients received fibrinolytic drugs in the preceding 4 days * Bleeding diathesis * Known bleeding disorder * Low platelet count (\< 100.000/uL * Gastrointestinal bleeding in the preceding 3 month * Any ongoing known presence of malignant neoplasia months * Advanced chronic kidney disease (defined as 11.000/uL) * Gastrointestinal bleeding in the preceding 3 month * Any ongoing known presence of malignant neoplasia at admission with survival rate \< 6 * Advanced chronic kidney disease (defined as eGFR \< 30 ml/min or on dialysis)

Primary outcome measure(s)

  • development of pulmonary hypertension — 6 months from treatment
    number of cases

Trial sites (1)

FacilityCityRegionStatus
ASST GOM Niguarda Milan Italia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06143969 on ClinicalTrials.gov ↗ ← All trials in Italy