Comparison of Two Pulmonary Embolism Treatments

The primary objective of this trial is to evaluate the safety and efficacy of treatment with anticoagulation alone versus anticoagulation and mechanical aspiration thrombectomy with the Indigo Aspiration System for the treatment of intermediate-high risk acute pulmonary embolism (PE).

Inclusion Criteria:Age 18-80 years oldClinical signs and symptoms consistent with acute PE with duration of 14 days or lessObjectively confirmed acute PE, based on computed tomographic pulmonary angiography (CTPA) imaging showing a filling defect in at least one main or proximal lobar pulmonary arteryClassification of intermediate high-risk PE as demonstrated by right ventricular dysfunction with RV/LV ratio ≥1.0 on CTPA and elevated cardiac biomarkers, including cardiac troponin, BNP and/or NT-pro BNP above the upper limit of normalJugular or femoral access deemed suitable to accommodate pulmonary artery intervention with the Indigo Aspiration SystemInformed consent is obtained from either the patient or legally authorized representative (LAR)Exclusion Criteria:Administration of thrombolytic agents or glycoprotein IIb/IIIa receptor antagonist within 30 days prior to baseline imagingHemodynamic instability with any of the following present:Cardiac arrestObstructive shock or persistent hypotension defined as systolic blood pressure (BP) <90 mmHg or an acute drop in systolic BP ≥40 mmHg for >15 min, or requiring vasopressor or inotropic support to achieve a systolic BP ≥90 mmHgPatients on ECMONational Early Warning Score (NEWS) 2 ≥9History, imaging or hemodynamic findings consistent with chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease (CTED) diagnosisImaging evidence or other evidence that suggests, in the opinion of the Investigator, that catheter-based intervention is not appropriate for the patientAllergy, hypersensitivity, or heparin induced thrombocytopenia (HIT)Contraindication or sensitivity to iodinated intravascular contrast that cannot be adequately premedicatedSevere active infection (e.g. sepsis) requiring treatment at time of enrollmentActive bleeding or disorders contraindicating anticoagulant therapyHemoglobin <10 g/dLPlatelets <100,000/μLINR >3Patients on chronic antiplatelet or anticoagulation therapy, except low-dose acetylsalicylic acid or clopidogrel 75 mg once dailyCardiovascular or pulmonary surgery within last 7 daysStage III/IV cancer or cancer or tumor which requires active chemotherapy or radiation therapy during the course of the trialLife expectancy <90 daysPregnancyIntracardiac thrombus (right atrium, right ventricle clot in transit) identified on baseline imagingCurrent participation in another investigational drug or device trial that may confound the results of this trial. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies.