NCT06672510 · Akura Medical
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)
What this study is about
This study is a forward-looking, single-treatment group$1, interventional, conducted at multiple hospitals study to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the Akura Thrombectomy System in subjects with acute pulmonary embolism (PE).
View original scientific description
This study is a prospective, single-arm, interventional, multicenter study to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the Akura Thrombectomy System in subjects with acute pulmonary embolism (PE).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
Where
- Thousand Oaks, California
- Thornton, Colorado
- Hartford, Connecticut
- Bradenton, Florida
- Jacksonville, Florida
- Tallahassee, Florida
- Saint Cloud, Minnesota
- New York, New York
- Toledo, Ohio
- Nashville, Tennessee
- San Antonio, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 17, 2025 · Source of record for eligibility and locations