CLEANer Aspiration for Pulmonary Embolism

To evaluate the safety and efficacy of the Cleaner™ Pro Thrombectomy System for aspiration thrombectomy in patients with acute pulmonary embolism (PE).

Inclusion Criteria: * At least 18 years of age at the time of consent * Clinical signs, symptoms, and presentation consistent with acute PE * Onset of PE symptoms occurred within 14 days of presentation * Filling defect in at least one main or lobar pulmonary artery evidenced by CTA * RV dysfunction on CTA or echocardiography defined as RV/LV ratio \>0.9 Exclusion Criteria: * tPA use within 14 days prior to baseline CTA * Systolic BP \70 mmHg by right heart catheterization or elevated main pulmonary artery to aorta ratio (MPA:A), up to investigator discretion. * History of severe or chronic pulmonary hypertension * FiO2 requirement \>40% or \>6 LPM to keep oxygen saturations \>90% * Hematocrit \3 * aPTT (or PTT) \>50 seconds on no anticoagulation * History of heparin-induced thrombocytopenia (HIT) * Recent (within six months) history of stroke, transient ischemic attack (TIA), or intracranial bleeding * Recent (within one month) history of active bleeding from a major organ * Absolute contraindication to anticoagulation * Major trauma such as head trauma, or other active intracranial, or intraspinal disease within 14 days * Presence of intracardiac lead in the right ventricle or right atrium placed within 6 months * Cardiovascular or pulmonary surgery within last 7 days * Cancer which requires active chemotherapy * Known serious, uncontrolled sensitivity to radiographic agents * Life expectancy \