New Clot-Busting catheter procedure could ease recovery for lung blood clot patients
NCT ID NCT05591118
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2023
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
40 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Advocate Good Samaritan Hospital
RECRUITINGDowners Grove, Illinois, 60515, United States
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Baptist Health Miami Cardiac & Vascular Institute
RECRUITINGMiami, Florida, 33176, United States
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Beth Israel Deaconess Medical Center
RECRUITINGBoston, Massachusetts, 02215, United States
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Boston Medical Center
RECRUITINGBoston, Massachusetts, 02118, United States
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Carilion Clinic
RECRUITINGRoanoke, Virginia, 24014, United States
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Christiana Care
RECRUITINGNewark, Delaware, 19718, United States
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Emory University School of Medicine
RECRUITINGAtlanta, Georgia, 30308, United States
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Icahn School of Medicine at Mount Sinai
RECRUITINGNew York, New York, 10029, United States
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Intermountain Health
RECRUITINGMurray, Utah, 84107, United States
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Lifespan
RECRUITINGProvidence, Rhode Island, 02903, United States
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Loyola University Chicago
RECRUITINGMaywood, Illinois, 60153, United States
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Main Line Healh
RECRUITINGWynnewood, Pennsylvania, 19096, United States
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MaineHealth
RECRUITINGPortland, Maine, 04102, United States
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MedStar Health Research Institute
RECRUITINGWashington D.C., District of Columbia, 20010, United States
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Medical College of Wisconsin
RECRUITINGMilwaukee, Wisconsin, 53226, United States
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Medical University of South Carolina
RECRUITINGCharleston, South Carolina, 29425, United States
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NYU Langone Health - Tisch Hospital
RECRUITINGNew York, New York, 10016, United States
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Oregon Health & Science University
RECRUITINGPortland, Oregon, 97239, United States
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Promedica
RECRUITINGToledo, Ohio, 43606, United States
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Rutgers New Jersey Medical School
RECRUITINGNewark, New Jersey, 07103, United States
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Scripps Memorial Hospital, La Jolla
RECRUITINGSan Diego, California, 92121, United States
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Sentara Health Research Center
RECRUITINGNorfolk, Virginia, 23507, United States
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Southern Illinois University School of Medicine
RECRUITINGSpringfield, Illinois, 62781, United States
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Stanford Medicine
RECRUITINGPalo Alto, California, 94304, United States
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The Lundquist Institute
RECRUITINGTorrance, California, 90502, United States
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The University of Alabama At Birmingham
RECRUITINGBirmingham, Alabama, 35233, United States
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The University of Texas Health Science Center at Houston
RECRUITINGHouston, Texas, 77030, United States
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Thomas Jefferson University
RECRUITINGPhiladelphia, Pennsylvania, 19107, United States
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Trinity Health - Ann Arbor Hospital
RECRUITINGYpsilanti, Michigan, 48197, United States
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UC Davis Health
RECRUITINGSacramento, California, 95817, United States
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University of Chicago Medical Center
RECRUITINGChicago, Illinois, 60637, United States
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University of Iowa
RECRUITINGIowa City, Iowa, 52242, United States
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University of Michigan
RECRUITINGAnn Arbor, Michigan, 48109, United States
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University of New Mexico Health Sciences Center
RECRUITINGAlbuquerque, New Mexico, 87131, United States
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University of Pennsylvania
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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University of Pittsburgh Medical Center
RECRUITINGPittsburgh, Pennsylvania, 15232, United States
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University of South Florida/ Tampa General Hospital
RECRUITINGTampa, Florida, 33606, United States
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University of Utah Health
RECRUITINGSalt Lake City, Utah, 84108, United States
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Washington University in St. Louis
RECRUITINGSt Louis, Missouri, 63110, United States
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Weill Cornell Medicine
RECRUITINGNew York, New York, 10065, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can electronic alerts and patient teaching stop deadly clots after cancer surgery?
- Can a new Five-Category system predict which pulmonary embolism patients will crash?
- A new exercise plan aims to get pulmonary embolism survivors back on their feet
- Spotting hidden blood clots in scarred lungs: a study hunts for clues
- Decades-Long study of 121,700 nurses aims to uncover hidden heart disease triggers
- Massive chest pain registry reveals gaps between guidelines and real-world care in china