Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy
ConditionPulmonary Embolism
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNYU Langone Health
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Anticoagulant Therapy
- Catheter-Directed Therapy
Treatment groups
500 Participants
are divided into 2 treatment groupsSponsors and collaborators
NYU Langone Health
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov