Evaluating the Akura Thrombectomy System for removing blood clots in the lungs

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)

This study is testing a new device to see if it can safely and effectively remove blood clots from the lungs in patients with acute pulmonary embolism.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 118 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Akura Medical (industry)
• Locations: 12 sites (Thousand Oaks, California and 11 other locations)
• Trial ID: NCT06672510 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of the Akura Thrombectomy System for the removal of blood clots from the pulmonary arteries in patients with acute pulmonary embolism. It is a prospective, single-arm, interventional, multicenter study involving patients who present with symptoms consistent with acute PE. Participants will undergo a percutaneous mechanical thrombectomy procedure to assess the system's performance in treating this condition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with clinical signs of acute pulmonary embolism and specific imaging findings.

Not a fit: Patients with a history of pulmonary embolism within the last 180 days or those requiring significant vasopressor support may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new, effective option for patients suffering from acute pulmonary embolism.

How similar studies have performed: Other studies have explored mechanical thrombectomy for pulmonary embolism, showing promising results, but this specific approach with the Akura Thrombectomy System is relatively novel.

Eligibility criteria

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 this trial is running

Thousand Oaks, California and 11 other locations

• Los Robles Regional Medical Center — Thousand Oaks, California, United States (RECRUITING)
• Advanced Heart & Vein (ClinRe-001-001) — Thornton, Colorado, United States (RECRUITING)
• Hartford Healthcare — Hartford, Connecticut, United States (RECRUITING)
• Manatee Hospital / Nova Clinical Research Center — Bradenton, Florida, United States (ACTIVE_NOT_RECRUITING)
• Jacksonville Memorial (HCA) — Jacksonville, Florida, United States (ACTIVE_NOT_RECRUITING)
• Tallahasse Memorial Hospital — Tallahassee, Florida, United States (RECRUITING)
• Centracare Heart & Vascular Center — Saint Cloud, Minnesota, United States (RECRUITING)
• Columbia University Medical Center — New York, New York, United States (NOT_YET_RECRUITING)
• Cumc/Nyph — New York, New York, United States (NOT_YET_RECRUITING)
• ProMedica Toledo Hospital — Toledo, Ohio, United States (RECRUITING)
• Tristar Centennial Medical Center — Nashville, Tennessee, United States (RECRUITING)
• Methodist San Antonio (HCA) — San Antonio, Texas, United States (RECRUITING)

Study contacts

• Study coordinator: Rukhsana Khanum

Conditions: Pulmonary Embolism Acute