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Akura Thrombectomy System for Acute Pulmonary Embolism

This study is testing a new device called the Akura Thrombectomy System. It's designed to remove blood clots (emboli) from the lung arteries (pulmonary arteries) in people who have a sudden blood clot in their lungs (acute pulmonary embolism, or PE). Researchers want to see how safe and effective this system is. You might be able to join if you are 18 or older, have acute PE symptoms for 14 days or less, and have specific findings on a CT scan of your lungs. The study will measure how well the device works and if there are any serious problems within 48 hours after the procedure. The current recruitment status is unclear, but the study plans to enroll 118 participants.

Study design
This is a single-arm study, meaning all participants will receive the Akura Thrombectomy System. It plans to enroll 118 participants across multiple centers.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and effectiveness will be measured at 48 hours after the procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06672510

Safety and Effectiveness of the Akura Thrombectomy System for Use in the Removal of Emboli From the Pulmonary Arteries in Treating Acute Pulmonary Embolism (PE)

Suspended
NAAges 18+InterventionalTreatment
Akura Medical
~118 participants
Updated 2026-08-31 on ClinicalTrials.gov
What's tested:ATC

At a glance

Recruiting sites
0 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Effectiveness
Measured over 48 hours
+1 more outcome measured

Conditions

Pulmonary Embolism Acute

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Pulmonary Embolism

NCT06672510

Where you'd take part

This study runs at 7 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Cumc/Nyph

    New York, New Yorkno site contact published

  • Hartford Healthcare

    Hartford, Connecticutno site contact published

  • Los Robles Regional Medical Center

    Thousand Oaks, Californiano site contact published

  • Manatee Memorial Hospital / Nova Clinical Research Center

    Bradenton, Floridano site contact published

  • ProMedica Toledo Hospital

    Toledo, Ohiono site contact published

  • Tallahassee Memorial Hospital

    Tallahassee, Floridano site contact published

  • Tristar Centennial Medical Center

    Nashville, Tennesseeno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

The patient is 18 years of age or older and deemed medically eligible for interventional procedure, per institutional guidelines and clinical judgement
Clinical signs, symptoms and presentation consistent with acute PE
PE symptom duration ≤ 14 days
CTA evidence of proximal PE (filling defect in at least one main or lobar pulmonary artery)
CTA evidence of RV/LV ratio of ≥ 0.9 (NOTE: Enrollment qualification assessment is based on the Investigator's interpretation of RV/LV ratio at baseline)
Systolic BP ≥ 90 mmHg (initial SBP may be \< 90 mmHg but ≥ 80 mmHg if the pressure recovers with volume resuscitation)
Stable HR \< 130 BPM prior to the procedure

Exclusion

Prior PE \<180 days from index procedure
Thrombolytic use within 30 days prior to baseline CTA
Pulmonary hypertension with peak pulmonary arterial pressure (PAP) \> 70 mmHg by right heart catheterization
Vasopressor requirement after fluids to keep pressure at ≥ 90 mmHg
FiO2 requirement \> 40% or \> 6 LPM (to keep oxygen saturation \> 90%)
Hematocrit \< 28% (Note: hematocrit required within 6 hrs. of index procedure)
Platelets \< 100,000/μL
eGFR \<30 ml/min per 1.73 m2
International normalized ratio (INR) \> 3
Major trauma injury severity score (ISS) \> 15
Presence of intracardiac lead in right ventricle or atrium placed ≤ 6 months of enrollment
Cardiovascular or pulmonary surgery within the last 7 days
Actively progressing cancer treated by chemotherapeutics
Known bleeding diathesis or coagulation disorder
Left bundle branch block
History of severe or chronic pulmonary arterial hypertension
History of chronic left heart disease with left ventricular ejection fraction ≤ 30%
History of uncompensated heart failure.
History of underlying lung disease that is oxygen dependent
History of chest irradiation
History of heparin-induced thrombocytopenia (HIT)
Contraindication to systemic or therapeutic doses of anticoagulants
Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
Known residual iliac deep vein thrombosis (DVT), inferior vena cava (IVC) clot or clot in transit (right atrium and/or right ventricle)
CTA imaging or other evidence that suggest, in the opinion of the investigator, the Subject is not appropriate for mechanical thrombectomy intervention (e.g. inability to navigate to target location, predominantly chronic clot or non-clot embolus)
Life expectancy \< 90 days, as determined by investigator (e.g., stage 4 cancer, frailty or severe COVID infections)
Female who is pregnant or nursing
Current participation in another investigational drug or device treatment study

What this trial measures

  • Effectiveness48 hours

    Change in RV/LV ratio from baseline

  • Safety: Composite of Major Adverse Device-Related Events48 hours post index procedure

    Device-related major bleeding at access, device-related death, clinical deterioration, pulmonary vascular injury or cardiac injury