Pulmonary Embolism Acute
Conditions
Brief summary
This study is a prospective, single-arm, interventional, multicenter study to evaluate the safety and effectiveness of the ATC 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 for \< 14 days 3. CTA evidence of proximal PE 4. RV/LV ratio \> 0.9 5. Systolic BP ≥90 mmHg without the need for vasopressors 6. Stable heart rate (HR) \< 130 BPM prior to procedure 7. Patient is deemed medically eligible for interventional procedure(s), per investigator guidelines and clinical judgment 8. 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 \< 30 days prior to baseline CTA 3. Pulmonary hypertension with peak pulmonary artery systolic pressure (PASP) \>70 mmHg by right heart catheterization 4. FiO2 requirement \>40% or \>6 LPM to keep oxygen saturation \>90% 5. Hematocrit \<28% 6. Platelets count \<100,000/µL 7. Serum creatinine \>1.8 mg/dL 8. International normalized ratio (INR) \>3 9. Major trauma injury severity score (ISS) \>15 prior to screening assessment 10. Presence of intracardiac lead in right ventricle or atrium placed within 6 months prior to screening assessment 11. Cardiovascular or pulmonary surgery within 7 days of index procedure 12. Actively progressing cancer treated by chemotherapeutics 13. Known bleeding diathesis or coagulation disorder 14. Left bundle branch block 15. History of severe or chronic pulmonary arterial hypertension 16. History of chronic left heart disease with left ventricular ejection fraction ≤ 30% 17. History of decompensated heart failure 18. History of underlying lung disease that is oxygen dependent 19. History of chest irradiation 20. History of heparin-induced thrombocytopenia (HIT) 21. Contraindication to systemic or therapeutic doses of anticoagulants 22. Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated 23. Imaging evidence or other evidence that suggest, in the opinion of the investigator, the Subject is not appropriate for aspiration thrombectomy intervention 24. Life expectancy \<90 days, as determined by investigator such as stage 4 cancer, frailty or severe COVID infections 25. Female who is pregnant or nursing 26. Current participation in another investigational drug or device treatment study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness | 48 hours post index procedure | Change in RV/LV ratio |
| 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
Brazil, Dominican Republic
Outcome results
None listed