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New Ultrasound-Guided clot treatment aims to save lungs and hearts

NCT ID NCT06310018

Disease control Sponsor: Brigham and Women's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a procedure that uses ultrasound and a catheter to deliver a low dose of a clot-dissolving drug directly to blood clots in the lungs. The goal is to quickly reduce the strain on the heart and improve blood flow, while keeping the risk of serious bleeding low. The trial includes 60 adults with severe but stable pulmonary embolism and signs of heart stress.

What this could mean

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

Active substance
Tissue plasminogen activator (tPA) - a clot-dissolving drug
What this could lead to
If successful, this could offer a safer, lower-dose way to treat dangerous blood clots in the lungs, reducing heart strain and bleeding complications.
What could go wrong
This is an early, single-arm study with only 60 participants, so results may not apply broadly. The trial is currently suspended, and bleeding risks remain a concern.

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 60 people

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

Expected to start

Jan 2027

An estimate. Start dates often move.

Expected to finish

Dec 2028

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 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.

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: 1. patients at least 18 years of age, 2. 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 3. in whom ultrasound-facilitated, catheter-directed lower-dose fibrinolysis has been selected for treatment on a clinical basis. Exclusion Criteria: 1. stroke or transient ischemic attack, head trauma, other active intracranial or intraspinal disease (including malignancy) within 1 year 2. recent active bleeding from a major organ within 1 month 3. major surgery within 7 days of screening 4. contraindication to therapeutic anticoagulation 5. 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 6. need for mechanical ventilation, including non-invasive positive pressure ventilation 7. hematocrit \<30%, platelet count \<100,000/μl 8. international normalized ratio \>3 9. serum creatinine \> 2 mg/dL 10. liver cirrhosis 11. known hypersensitivity to tPA, heparin, or any excipients 12. perceived high risk for fatal or catastrophic bleeding 13. prescription of dual antiplatelet therapy (DAPT) at time of screening 14. Patients treated with any other advanced therapy, such as surgical embolectomy, catheter-based mechanical embolectomy, or fibrinolytic therapy, within the prior 30 days 15. pregnancy or lactation

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Conditions

The condition(s) this trial relates to.

heart failure pulmonary embolism Ventricular Dysfunction, Right

As listed by the trial registrant

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

Pulmonary embolism Right ventricular dysfunction Right ventricular failure

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.