Can a catheter device clear lung clots and ease heart strain?

NCT ID NCT06362928

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
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This trial tests a device called the Akura Thrombectomy System, which is threaded through a catheter to mechanically remove blood clots from the lungs. The study enrolls adults with acute pulmonary embolism, a condition where clots block blood flow in the lungs and strain the heart. Researchers measure whether the device restores blood flow and reduces heart strain, and they track safety events like bleeding or injury to the lungs or heart.

What this could mean

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

Active substance
Akura Thrombectomy System, a catheter-based device that mechanically removes blood clots from the pulmonary arteries
What this could lead to
If it works, this device could offer a faster, less invasive way to clear clots from the lungs and reduce heart strain in people with acute pulmonary embolism.
What could go wrong
This is an early feasibility study, so the device may not prove safe or effective. Risks include bleeding, damage to blood vessels or the heart, and clinical deterioration.

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.

Started

Feb 2025

Finished

Jun 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.

Inclusion Criteria: 1. Patient is \> 18 and \< 90 years old 2. Clinical signs and symptoms consistent with acute PE 3. PE symptom duration ≤ 14 days 4. CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery as determined by the investigator) 5. CTA evidence of RV/LV ratio \> 0.9 note: based on Investigator's interpretation of RV/LV ratio at baseline; 6. Systolic BP ≥ 90 mmHg note: initial SBP may be \< 90 mmHg but ≥ 80 mmHg if the pressure recovers with volume resuscitation 7. Stable heart rate (HR) \< 130 BPM prior to procedure 8. Patient is deemed medically eligible for interventional procedure(s), per investigator guidelines and clinical judgment. 9. Subject or legally authorized representative (LAR) is willing and able to provide written informed consent prior to receiving any non-standard of care protocol specific procedures Exclusion Criteria: 1. Prior PE \< 180 days from index procedure 2. Thrombolytic use \< 48 hours prior to baseline CTA 3. Pulmonary hypertension with peak pulmonary artery systolic pressure (PASP) \>70 mmHg by right heart catheterization 4. Vasopressor requirement after fluids to keep pressure at ≥90 mmHg 5. FiO2 requirement \>40% or \>6 LPM to keep oxygen saturation \>90% 6. Hematocrit \<28% (Note: hematocrit required within 6 hrs. of index procedure) 7. Platelets count \<100,000/µL 8. eGFR \<30 ml/min per 1.73 m2 9. International normalized ratio (INR) \>3 10. Major trauma injury severity score (ISS) \> 15 11. Presence of intracardiac lead in right ventricle or atrium placed within 6 months prior to screening assessment 12. Cardiovascular or pulmonary surgery within 7 days of index procedure 13. Actively progressing cancer treated by chemotherapeutics 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. History of underlying lung disease that is oxygen dependent 20. History of chest irradiation 21. History of heparin-induced thrombocytopenia (HIT) 22. Contraindication to systemic or therapeutic doses of anticoagulants 23. Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated 24. Known residual iliac deep vein thrombosis (DVT), inferior vena cava (IVC) clot or clot in transit (right atrium and/or right ventricle). 25. CTA imaging or other evidence that suggest, in the opinion of the investigator, the Subject is not appropriate for aspiration thrombectomy intervention (e.g., inability to navigate to target location, predominantly chronic clot or non-clot embolus) 26. Life expectancy \<90 days, as determined by investigator 27. Female who is pregnant or nursing 28. Current participation in another investigational drug or device treatment study Note: observational or registry studies may be permitted with Sponsor approval

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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.

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