Pulmonary Embolism Acute
Conditions
Brief summary
This study is a prospective, single-arm, non-randomized, interventional, multicenter feasibility 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 System
The ATC System is designed to mechanically remove emboli and restore blood flow through the pulmonary arteries in patients experiencing acute PE
Sponsors
Akura Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness | 48 hours | Change in RV/LV ratio post index procedure |
| 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 |
Outcome results
None listed