Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy
NYU Langone Health
500 participants
Jul 17, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria2
- 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 Criteria14
- 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
- Chronic 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
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Interventions
All subjects will receive anticoagulation for a minimum of 3 months.
The endovascular physician can choose to use either mechanical thrombectomy (MT) using a device cleared by the FDA to treat PE or catheter-directed thrombolysis (CDL) using an infusion catheter cleared by the FDA to administer thrombolytic drugs for the treatment of PE
Locations(40)
View Full Details on ClinicalTrials.gov
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NCT05591118