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New Clot-Busting catheter shows promise for lung blood clots

NCT ID NCT05597891

Disease control Sponsor: Endovascular Engineering 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new device called the Hēlo PE Thrombectomy System, which is a thin tube used to remove blood clots from the lungs in people with a serious condition called pulmonary embolism. The trial included 177 participants and aimed to see if the device is safe and works well. The main goal was to reduce the strain on the heart caused by the clot, measured by a heart imaging test, within 48 hours of the procedure.

What this could mean

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

Active substance
Hēlo PE Thrombectomy System (a catheter device used to remove blood clots from the lungs)
What this could lead to
If this device works well, it could offer a new, less invasive way to quickly remove dangerous blood clots from the lungs, potentially reducing complications and improving recovery for people with pulmonary embolism.
What could go wrong
This is an early feasibility study with no comparison group, so results may not prove the device is better than standard treatments. There are also risks of bleeding, vessel injury, or other serious complications during the procedure.

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

177 people

The number who actually took part.

Started

Jan 2023

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 90 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.

Asterisks \* indicate entry criteria that can be evaluated during prescreening without obtaining informed consent as they are part of standard of care PE management. Asterisks in parenthesis (\*) indicate entry criteria that can be evaluated during prescreening without obtaining informed consent at Sites that routinely perform CTA as part of standard of care in PE management. Inclusion Criteria: Patients must meet ALL of the following criteria to be eligible for participation in the study: 1. \*Patient is \> 18 and \< 90 years old 2. \*Clinical signs and symptoms consistent with acute submassive PE with duration ≤ 14 days, as determined by the Investigator 3. (\*)CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery) 4. (\*)RV/LV ratio of ≥ 0.9 (Enrollment qualification assessment based on Investigator's interpretation of RV/LV ratio at baseline) 5. \*Systolic blood pressure ≥ 90 mmHg (initial SBP may be ≥ 80 mmHg if the pressure recovers to ≥ 90 mmHg with fluids) 6. \*Heart rate \< 130 BPM prior to procedure 7. \*Patient is deemed medically eligible for interventional procedure(s), per investigator guidelines and clinical judgment 8. Patient signs a written Informed Consent form to participate in the study, prior to any study mandated procedures Exclusion Criteria: Patients must be EXCLUDED from participation in this study if ANY of the following criteria are met: 1. \*Acute massive PE at presentation 2. \*Prior PE within last 6 months 3. \*Thrombolytic use within 30 days of baseline CTA 4. \*Pulmonary hypertension with peak pulmonary artery systolic pressure \> 70 mmHg by right heart catheterization 5. \*Vasopressor requirement after fluids to keep pressure ≥ 90 mmHg 6. \*FiO2 requirement \> 40% or \> 6 LPM to keep oxygen saturation \> 90% 7. \*Hematocrit \< 28% (NOTE: hematocrit required within 24 hours of index procedure) 8. \*Platelets \< 100,000/μL 9. \*Serum creatinine \> 1.8 mg/dL 10. \*International normalized ratio (INR) \> 3 11. \*aPTT (or PTT) \> 50 seconds on no anticoagulation 12. \*Major trauma \< 14 days 13. \*Presence of intracardiac lead in the right ventricle or right atrium placed within 6 months 14. \*Cardiovascular or pulmonary surgery within last 7 days 15. \*Life expectancy less than 1 year due to advanced malignancy, as determined by the investigator at the time of enrollment 16. \*Known bleeding diathesis or coagulation disorder 17. \*Known left bundle branch block 18. \*History of severe pulmonary arterial hypertension 19. \*History of chronic left heart disease with left ventricular ejection fraction ≤ 30% 20. \*History of uncompensated heart failure 21. \*History of underlying lung disease that is oxygen dependent 22. \*Presence of IVC filter and or iliocaval stents 23. \*History of heparin-induced thrombocytopenia (HIT) 24. \*Any contraindication to systemic or therapeutic doses of heparin or anticoagulants 25. \*Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated 26. \*Known allergy to any device component 27. (\*)Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the Subject is not appropriate for mechanical thrombectomy intervention (e.g., inability to navigate to target location, predominately chronic clot or non-clot embolus) 28. \*Life expectancy of \< 90 days, as determined by Investigator 29. \*Female who is pregnant or nursing 30. \*Current participation in another investigational drug or device treatment 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

Contacts and locations

Locations

  • Austin Heart

    Austin, Texas, 78705, United States

  • Baptist Health Research Institute

    Jacksonville, Florida, 32207, United States

  • Baylor Scott & White Research Institute

    Dallas, Texas, 75204, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02215, United States

  • Delray Medical Center

    Delray Beach, Florida, 33484, United States

  • Gundersen Health

    La Crosse, Wisconsin, 54601, United States

  • HCA Florida Memorial Hospital

    Jacksonville, Florida, 32216, United States

  • Huntington Hospital

    Pasadena, California, 91105, United States

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • Northside Hospital

    Atlanta, Georgia, 30342, United States

  • PIH Health Good Samaritan Hospital

    Los Angeles, California, 90017, United States

  • Piedmont Heart

    Atlanta, Georgia, 30309, United States

  • Temple University

    Philadelphia, Pennsylvania, 19122, United States

  • Tennova Healthcare - Turkey Creek Medical Center

    Knoxville, Tennessee, 37934, United States

  • The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    Torrance, California, 90502, United States

  • Torrance Memorial Medical Center

    Torrance, California, 90505, United States

  • TriHealth Hatton Research Institute

    Cincinnati, Ohio, 45242, United States

  • UT Health

    Houston, Texas, 77030, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Wellmont Cardiology Services / Ballad Health

    Kingsport, Tennessee, 37660, United States

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