About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Age < 18 years old
Patients unable to give informed consent
Pregnancy
Patients received fibrinolytic drugs in the preceding 4 days
Trial population
patients hospitalized with intermediate high-risk pulmonary embolism
Trial design
Cohort
Prospective
Treatments tested in this trial
ultrasound-assisted, catheter-directed thrombolysis
Procedure/SurgeryAfter 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.
Treatment groups
Trial outcomes
Primary outcomes
development of pulmonary hypertension
number of cases
Secondary outcomes
changes of echocardiographic parameters
* tricuspid annular plane excursion (TAPSE) (mm) * right ventricle/left ventricle ratio (RV/LV) ratio (decimal) * acceleration time (ACT) time (seconds) * fractional area change (FAC) * S' TDI RV (cm/sec) * pulmonary artery systolic pressure (PAPs) (mmHg) * tricuspid regurgitant velocity (TRV) (m/s)
death
death during hospital stay (number of events)
death
death from any cause (cancer, sepsis, respiratory failure, other) number of events
PE
PE recurrence (number of events)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.