This study tests a new medical device called the Cleaner™ Pro Thrombectomy System that is designed to remove blood clots from the lungs in patients with pulmonary embolism (a serious condition where a blood clot blocks blood flow in the lungs). Researchers will evaluate how safe and effective this device is at treating this life-threatening condition. The goal is to determine if this aspiration (suction-based) approach can successfully remove clots and improve patient outcomes.
Key Objective: This trial is testing whether the Cleaner™ Pro device can safely and effectively remove blood clots from the lungs to improve treatment outcomes for patients with acute pulmonary embolism.
Who to Consider: Patients diagnosed with acute pulmonary embolism who meet the study's eligibility criteria and are interested in potentially receiving this newer thrombectomy treatment should consider enrolling.
Trial Parameters
Brief Summary
To evaluate the safety and efficacy of the Cleaner™ Pro Thrombectomy System for aspiration thrombectomy in patients with acute pulmonary embolism (PE).
Eligibility Criteria
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 \<90 mmHg for 15 min or the requirement of inotropic support to maintain systolic BP ≥90 mmHg * Diagnosis of pulmonary hypertension primary type I or CTEPH; if patient does not have diagnosis of pulmonary hypertension but peak PA \>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 \<28% * Platelets \<100,000/µL * Serum creatinine \>1.8 mg/dL * IN