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New catheter aims to treat dangerous blood clots in the lungs without ICU stay

NCT ID NCT06433011

Disease control Sponsor: Thrombolex, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This trial tests a special catheter that delivers clot-dissolving medication directly into the lung arteries of people with intermediate-risk pulmonary embolism. The goal is to see if this targeted approach can safely treat the clot without needing intensive care or a continuous drug drip. About 500 participants will receive the treatment and be followed for 7 to 30 days.

What this could mean

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

Active substance
a catheter that delivers clot-busting drugs directly into the pulmonary arteries
What this could lead to
If successful, this approach could offer a less invasive treatment for pulmonary embolism that avoids intensive care and reduces complications.
What could go wrong
This is an early-stage device trial with 500 participants, so results may not apply to all patients. Risks include bleeding, vessel damage, or the procedure not improving outcomes.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 500 people

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

Started

Oct 2024

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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. Willing and able to provide informed consent; 2. PE symptom duration ≤ 15 days; 3. Filling defect in at least one major lobar pulmonary artery as determined by CTA; 4. Patient is diagnosed with intermediate risk PE; 5. RV/LV diameter ratio ≥ 0.9 by CTA, as determined by investigative site; 6. Willing and able to comply with all study procedures and 7-day and 30-day telephone follow-up visit. Exclusion Criteria: 1. Previous history of stroke with residual hemiplegia; 2. Major surgery ≤ 10 days prior to inclusion in the study; 3. Platelet count \< 100,000/μL; 4. Pulmonary thrombectomy within the previous 4 days; 5. Uncontrolled hypertension defined as systolic blood pressure \>180 mm Hg and/or diastolic blood pressure \>110 mm Hg at the time of the procedure; 6. Administration of thrombolytic agents within the previous 4 days; 7. Absolute contraindication to anticoagulation; 8. Clinician deems high-risk for catastrophic bleeding; 9. Pregnancy; 10. Any vasopressor or inotropic support; 11. Cardiac arrest (including pulseless electrical activity (PEA) and asystole) requiring active cardiopulmonary resuscitation (CPR) during this hospitalization at treating institution and/or referring institution; 12. Planning to administer r-tPA by infusion after the r-tPA is administered by pulse sprays; 13. Currently participating in another study; 14. In the opinion of the investigator, the subject is not a suitable candidate for the study.

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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

    23 sites. 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

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02481, United States

  • Boston Medical Center

    RECRUITING

    Boston, Massachusetts, 02135, United States

  • Carondelet St. Joseph's Hospital

    RECRUITING

    Tuscon, Arizona, 85711, United States

  • Charleston Area Medical Center

    RECRUITING

    Charleston, West Virginia, 25304, United States

  • Community Health

    RECRUITING

    Indianapolis, Indiana, 46256, United States

  • Cooper Health

    RECRUITING

    Camden, New Jersey, 08103, United States

  • Dartmouth Hitchcock

    RECRUITING

    Lebanon, New Hampshire, 03756, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30308, United States

  • Honor Health

    RECRUITING

    Scottsdale, Arizona, 85258, United States

  • Jobst Vascular Institute - ProMedica Hospital

    RECRUITING

    Toledo, Ohio, 43606, United States

  • Lahey Hospital & Medical Center

    RECRUITING

    Burlington, Massachusetts, 01805, United States

  • Miami Valley/Wright State University/Premier Health

    RECRUITING

    Dayton, Ohio, 45435, United States

  • Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • North Mississippi Medical Center

    RECRUITING

    Tupelo, Mississippi, 38801, United States

  • Northwell Health

    RECRUITING

    Manhasset, New York, 11030, United States

  • Profound Research

    RECRUITING

    Hobart, Indiana, 46342, United States

  • Radiology and Imaging Specialists

    RECRUITING

    Lakeland, Florida, 33801, United States

  • Rush University Medical Center

    RECRUITING

    Chicago, Illinois, 60612, United States

  • Sentara

    RECRUITING

    Norfolk, Virginia, 23507, United States

  • St. Joseph's

    RECRUITING

    Liverpool, New York, 13088, United States

  • Temple University

    RECRUITING

    Philadelphia, Pennsylvania, 19140, United States

  • TriHealth

    RECRUITING

    Cincinnati, Ohio, 45242, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

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