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Sound waves and clot-busters: a new hope for PE survivors?

NCT ID NCT06143969

Disease control Sponsor: Niguarda Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tracks 180 people who had a serious but stable pulmonary embolism (a blood clot in the lung) and received a treatment that uses ultrasound waves to help a clot-busting drug work better. The main goal is to see if this approach reduces the chance of developing pulmonary hypertension (high blood pressure in the lungs) within six months. Researchers will also check heart function and other outcomes over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ultrasound-assisted, catheter-directed thrombolysis (procedure using EkoSonic system and alteplase)
What this could lead to
If successful, this could show that the procedure lowers the risk of developing pulmonary hypertension after a blood clot in the lungs.
What could go wrong
This is an observational study, not a randomized trial, so results may be less definitive. The procedure itself carries risks like bleeding or vessel damage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2022

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

patients hospitalized with intermediate high-risk pulmonary embolism

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

pulmonary embolism

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pulmonary embolism

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ASST GOM Niguarda

    RECRUITING

    Milan, Italia, 20162, Italy

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