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New device clears lung clots, eases heart strain in emergency study

NCT ID NCT06576427

Disease control Sponsor: Jupiter Endovascular Source: ClinicalTrials.gov ↗

What the study statuses mean

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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
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a device that removes blood clots from the main lung arteries in 123 people with a sudden pulmonary embolism. The goal was to reduce strain on the right side of the heart and prevent serious complications like major bleeding or heart injury. Participants were adults under 80 with symptoms for less than two weeks and evidence of a clot on a CT scan.

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

123 people

The number who actually took part.

Started

Oct 2024

Finished

Mar 2026

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

18 to 79 years

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. . Age ≥ 18 years \< 80 years 2. Acute onset of symptoms \< 14 days consistent with the presence of pulmonary embolism. 3. CTA evidence (site determined) of proximal PE (filling defect in at least one main or interlobar pulmonary artery) 4. RV/LV ratio of \> 0.9 on CTA as assessed by investigator (site determined). 5. Systolic blood pressure ≥ 90 mmHg (initial SBP may be ≥ 80 mmHg if the pressure recovers to ≥ 90 mmHg with fluids) 6. Subject or subject's legally authorized representative (LAR) - applicable for US is willing and able to provide written informed consent prior to receiving any non-standard of care Clinical Investigation Plan-specific procedures 7. Subject is willing and able to comply with all Clinical Investigation Plan required follow-up visits Exclusion Criteria 1. Thrombolytic use within 30 days of baseline CTA 2. Pulmonary hypertension with peak pulmonary artery pressure \> 70 mmHg by right heart catheterization (site determined) 3. Vasopressor requirement after fluids to keep pressure ≥ 90 mmHg 4. Unstable heart rate \> 130 beats per minute prior to procedure 5. FiO2 requirement \> 40% or \> 6 LPM to keep oxygen saturation \> 90% 6. Hematocrit \< 28% 7. Platelets \< 100,000/μL 8. Serum baseline creatinine \> 1.8 mg/dL 9. International normalized ratio (INR) \> 3 10. Major trauma injury severity score (ISS) \> 15 within the past 14 days 11. Presence of intracardiac lead in the right ventricle or right atrium placed \<180 days prior to the index procedure 12. Cardiovascular or pulmonary surgery within last 30 days 13. Actively progressing cancer requiring chemotherapy 14. Known bleeding diathesis or coagulation disorder 15. Left bundle branch block 16. History of severe or chronic pulmonary arterial hypertension 17. History of chronic left heart disease with left ventricular ejection fraction ≤ 30% 18. History of decompensated heart failure 19. Patients on extracorporeal membrane oxygenation (ECMO) 20. History of underlying lung disease that is oxygen dependent 21. History of chest irradiation 22. History of heparin-induced thrombocytopenia (HIT) 23. Contraindication to systemic or therapeutic doses of heparin or anticoagulants 24. Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated 25. Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the Subject is not appropriate for mechanical thrombectomy intervention 26. Life expectancy of \< 365 days, as determined by Investigator 27. Female who is pregnant or nursing 28. Current participation in another investigational drug or device treatment study 29. Inability to lay flat for procedure 30. Known presence of right-to-left cardiac shunt 31. History of Hemorrhagic or Ischemic Stroke, including Transient Ischemic Attack, within last 90 days 32. Current or history of chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease (CTED) diagnosis

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder Embolism Embolism and Thrombosis pulmonary embolism

As listed by the trial registrant

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

Pulmonary embolism

Contacts and locations

Locations

  • Ascension Sacred Heart

    Pensacola, Florida, 32504, United States

  • Baylor Scott & White

    Plano, Texas, 75024, United States

  • Carilion

    Roanoke, Virginia, 24014, United States

  • Duke University

    Durham, North Carolina, 27705, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • European Health Center Otwock

    Otwock, 05-400, Poland

  • Hartford Hospital

    Hartford, Connecticut, 06102, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Henry Ford St John

    Detroit, Michigan, 48236, United States

  • MUSC

    Charleston, South Carolina, 29425, United States

  • Medical University of Vienna

    Vienna, Austria

  • Medical University of Warsaw

    Warsaw, Poland

  • NYU Langone Health

    New York, New York, 10016, United States

  • Northwell Health

    Staten Island, New York, 10305, United States

  • Penn Presbyterian

    Philadelphia, Pennsylvania, 19104, United States

  • St Clair Health

    Pittsburgh, Pennsylvania, 15243, United States

  • St. John Paul II Hospital

    Krakow, Poland

  • Turkey Creek Medical Center

    Knoxville, Tennessee, 37934, United States

  • UPMC Presbyterian

    Pittsburgh, Pennsylvania, 15213, United States

  • University Hospital Basel

    Basel, 4031, Switzerland

  • University of North Carolina

    Chapel Hill, North Carolina, 27517, United States

  • Wake Forest Medical Center

    Winston-Salem, North Carolina, 27157, United States

  • Westchester Medical Center

    Valhalla, New York, 10595, United States

More trials for these conditions

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