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.

Stanford Investigator(s):

Andrew Kesselman, MD

Intervention(s):

drug: Anticoagulant Therapy

device: Catheter-Directed Therapy

Eligibility

Inclusion Criteria:

• Symptomatic PE diagnosed by contrast-enhanced CT angiography with involvement of a main or lobar pulmonary artery branch; and
• Right ventricular (RV) dilation as defined by the presence of an RV/Left ventricular ratio > 1 on CT angiography

Exclusion Criteria:

• Age < 18 years
• 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.
• Symptom duration > 14 days for the current PE episode
• Irreversible INR > 3
• Irreversible Thrombocytopenia (Platelets < 50,000/microliter)
• Creatinine > 2.0 mg/dl
• Hemoglobin < 7.0 g/dl
• Pregnancy (positive urine or blood pregnancy test (a pregnancy test must be obtained within 7 days prior to randomization in people of childbearing potential))
• 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
• Life expectancy < 1 year
• Inability to independently walk prior to the current PE episode (e.g. wheelchair dependent, walker or cane dependent, paraplegic, and/or bed-bound)
• Allergy to heparin or history of Heparin-Induced Thrombocytopenia (HIT)
• Unable or unwilling to provide informed consent
• Major contraindication or unsuitability for all CDT methods available at the Clinical Center

Ages Eligible for Study

18 Years and older

Genders Eligible for Study

All