Pulmonary Embolism – Thrombus Removal with Catheter-Directed (PE-TRACT)
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):
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
Recruiting
Contact Information
Stanford University School of Medicine
300 Pasteur Drive
Stanford, CA 94305
RAPID Server Access
To access the RAPID Server, please click HERE.
If you do not have a working login, please contact Derrick Laurel at
laureld@stanford.edu.