Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy

PE-TRACT is an open-label, assessor-blinded, randomized trial, aiming to compare catheter-directed therapy (CDT) and anticoagulation (CDT group) with anticoagulation alone (No-CDT) in 500 patients with submassive PE, proximal pulmonary artery thrombus and right ventricular dilation.

Inclusion Criteria: 1. Symptomatic PE diagnosed by contrast-enhanced CT angiography with involvement of a main or lobar pulmonary artery branch; and 2. Right ventricular (RV) dilation as defined by the presence of an RV/Left ventricular ratio \> 1 on CT angiography Exclusion Criteria: 1. Age \< 18 years 2. Systolic blood pressure \< 90 mmHg for \>15 consecutive minutes or \> 40 mmHg drop from baseline, or vasopressor requirement for blood pressure support (i.e., massive PE), occurring within 1 hour prior to eligibility assessment. 3. Symptom duration \> 14 days for the current PE episode 4. Irreversible INR \> 3 5. Irreversible Thrombocytopenia (Platelets \< 50,000/microliter) 6. Creatinine \> 2.0 mg/dl 7. Hemoglobin \< 7.0 g/dl 8. Pregnancy (positive urine or blood pregnancy test (a pregnancy test must be obtained within 7 days prior to randomization in people of childbearing potential)) 9. Allergy or hypersensitivity to Recombinant Tissue Plasminogen Activator (rt-PA), or iodinated contrast, except for mild-moderate contrast allergies for which steroid pre-medication can be used 10. Life expectancy \< 1 year 11. Chronic inability to independently walk prior to the current PE episode (e.g. wheelchair dependent, walker or cane dependent, paraplegic, and/or bed-bound) 12. Allergy to heparin or history of Heparin-Induced Thrombocytopenia (HIT) 13. Unable or unwilling to provide informed consent 14. Major contraindication or unsuitability for all CDT methods available at the Clinical Center