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)
Akura Medical
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).
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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 th…