Pulmonary Embolism Acute
Conditions
Brief summary
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).
Interventions
DEVICEATC
The ATC System is designed to mechanically remove emboli and restore blood flow through the pulmonary arteries in patients experiencing acute P
Sponsors
Akura Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness | 48 hours | Change in RV/LV ratio from baseline |
| Safety: Composite of Major Adverse Device-Related Events | 48 hours post index procedure | Device-related major bleeding at access, device-related death, clinical deterioration, pulmonary vascular injury or cardiac injury |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Composite of Major Adverse Events | 30 days post index procedure | Assessment of major adverse events through 30 day follow-up |
Countries
United States
Contacts
Primary ContactRukhsana Khanum
Backup ContactUday Illindala
Outcome results
None listed