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 groupsLocations
40Alabama
The University of Alabama At Birmingham35233, Birmingham United States
California
Stanford Medicine94304, Palo Alto United States
UC Davis Health95817, Sacramento United States
Scripps Memorial Hospital, La Jolla92121, San Diego United States
Sponsors and collaborators
NYU Langone Health
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov