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New Clot-Busting catheter procedure could ease recovery for lung blood clot patients

NCT ID NCT05591118

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether using a catheter to remove blood clots from the lungs, along with standard blood thinners, helps people with submassive pulmonary embolism recover better than blood thinners alone. About 500 adults with large clots and an enlarged right heart chamber will be randomly assigned to one of two groups. The goal is to see if the catheter procedure improves exercise ability and heart function while keeping bleeding risks low.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 500 people

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

Started

Jul 2023

Expected to finish

Aug 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.

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. Symptomatic PE diagnosed by contrast-enhanced CT angiography with involvement of a main or lobar pulmonary artery branch; and 2. Right ventricular (RV) dilation as defined by the presence of an RV/Left ventricular ratio \> 1 on CT angiography Exclusion Criteria: 1. Age \< 18 years 2. Systolic blood pressure \< 90 mmHg for \>15 consecutive minutes or \> 40 mmHg drop from baseline, or vasopressor requirement for blood pressure support (i.e., massive PE), occurring within 1 hour prior to eligibility assessment. 3. Symptom duration \> 14 days for the current PE episode 4. Irreversible INR \> 3 5. Irreversible Thrombocytopenia (Platelets \< 50,000/microliter) 6. Creatinine \> 2.0 mg/dl 7. Hemoglobin \< 7.0 g/dl 8. Pregnancy (positive urine or blood pregnancy test (a pregnancy test must be obtained within 7 days prior to randomization in people of childbearing potential)) 9. Allergy or hypersensitivity to Recombinant Tissue Plasminogen Activator (rt-PA), or iodinated contrast, except for mild-moderate contrast allergies for which steroid pre-medication can be used 10. Life expectancy \< 1 year 11. Chronic inability to independently walk prior to the current PE episode (e.g. wheelchair dependent, walker or cane dependent, paraplegic, and/or bed-bound) 12. Allergy to heparin or history of Heparin-Induced Thrombocytopenia (HIT) 13. Unable or unwilling to provide informed consent 14. Major contraindication or unsuitability for all CDT methods available at the Clinical Center

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    40 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

  • Advocate Good Samaritan Hospital

    RECRUITING

    Downers Grove, Illinois, 60515, United States

  • Baptist Health Miami Cardiac & Vascular Institute

    RECRUITING

    Miami, Florida, 33176, United States

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Boston Medical Center

    RECRUITING

    Boston, Massachusetts, 02118, United States

  • Carilion Clinic

    RECRUITING

    Roanoke, Virginia, 24014, United States

  • Christiana Care

    RECRUITING

    Newark, Delaware, 19718, United States

  • Emory University School of Medicine

    RECRUITING

    Atlanta, Georgia, 30308, United States

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Intermountain Health

    RECRUITING

    Murray, Utah, 84107, United States

  • Lifespan

    RECRUITING

    Providence, Rhode Island, 02903, United States

  • Loyola University Chicago

    RECRUITING

    Maywood, Illinois, 60153, United States

  • Main Line Healh

    RECRUITING

    Wynnewood, Pennsylvania, 19096, United States

  • MaineHealth

    RECRUITING

    Portland, Maine, 04102, United States

  • MedStar Health Research Institute

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • NYU Langone Health - Tisch Hospital

    RECRUITING

    New York, New York, 10016, United States

  • Oregon Health & Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Promedica

    RECRUITING

    Toledo, Ohio, 43606, United States

  • Rutgers New Jersey Medical School

    RECRUITING

    Newark, New Jersey, 07103, United States

  • Scripps Memorial Hospital, La Jolla

    RECRUITING

    San Diego, California, 92121, United States

  • Sentara Health Research Center

    RECRUITING

    Norfolk, Virginia, 23507, United States

  • Southern Illinois University School of Medicine

    RECRUITING

    Springfield, Illinois, 62781, United States

  • Stanford Medicine

    RECRUITING

    Palo Alto, California, 94304, United States

  • The Lundquist Institute

    RECRUITING

    Torrance, California, 90502, United States

  • The University of Alabama At Birmingham

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • The University of Texas Health Science Center at Houston

    RECRUITING

    Houston, Texas, 77030, United States

  • Thomas Jefferson University

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • Trinity Health - Ann Arbor Hospital

    RECRUITING

    Ypsilanti, Michigan, 48197, United States

  • UC Davis Health

    RECRUITING

    Sacramento, California, 95817, United States

  • University of Chicago Medical Center

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Iowa

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of New Mexico Health Sciences Center

    RECRUITING

    Albuquerque, New Mexico, 87131, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh Medical Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • University of South Florida/ Tampa General Hospital

    RECRUITING

    Tampa, Florida, 33606, United States

  • University of Utah Health

    RECRUITING

    Salt Lake City, Utah, 84108, United States

  • Washington University in St. Louis

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Weill Cornell Medicine

    RECRUITING

    New York, New York, 10065, United States

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