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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNiguarda Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • ultrasound-assisted, catheter-directed thrombolysis

    Procedure/Surgery

    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.

Treatment groups

180 Participants
are divided into 1 treatment group
Group A: EkoSonicTM Endovascular System (EKOSTM, Boston Scientific)1 intervention

Trial outcomes

Primary outcomes

1

development of pulmonary hypertension

number of cases

Time frame
6 months from treatment

Secondary outcomes

1

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)

Time frame
24 hours after the treatment and at 3-6 months follow-up
2

death

death during hospital stay (number of events)

Time frame
within 6 months from treatment
3

death

death from any cause (cancer, sepsis, respiratory failure, other) number of events

Time frame
within 6 months from treatment
4

PE

PE recurrence (number of events)

Time frame
within 6 months from treatment

Other outcomes

Sponsors and contacts

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