Safety and Effectiveness of the ATC System in the Treatment of Acute PE
Trial Parameters
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).
Eligibility Criteria
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. Inter