Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy

Recruiting now · Phase 3

Conditions studied: Pulmonary Embolism

In brief

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.

Key facts

Study ID

NCT05591118

Run by

NYU Langone Health

People needed

500

Starts

2023-07-17

Expected to finish

2027-08-04

Last updated by the study team

2026-05-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The University of Alabama At Birmingham — Birmingham, Alabama, United States (enrolling)
• Stanford Medicine — Palo Alto, California, United States (enrolling)
• UC Davis Health — Sacramento, California, United States (enrolling)
• Scripps Memorial Hospital, La Jolla — San Diego, California, United States (enrolling)
• The Lundquist Institute — Torrance, California, United States (enrolling)
• Christiana Care — Newark, Delaware, United States (enrolling)
• MedStar Health Research Institute — Washington D.C., District of Columbia, United States (enrolling)
• Baptist Health Miami Cardiac & Vascular Institute — Miami, Florida, United States (enrolling)
• University of South Florida/ Tampa General Hospital — Tampa, Florida, United States (enrolling)
• Emory University School of Medicine — Atlanta, Georgia, United States (enrolling)
• University of Chicago Medical Center — Chicago, Illinois, United States (enrolling)
• Advocate Good Samaritan Hospital — Downers Grove, Illinois, United States (enrolling)
• Loyola University Chicago — Maywood, Illinois, United States (enrolling)
• Southern Illinois University School of Medicine — Springfield, Illinois, United States (enrolling)
• University of Iowa — Iowa City, Iowa, United States (enrolling)
• MaineHealth — Portland, Maine, United States (enrolling)
• Boston Medical Center — Boston, Massachusetts, United States (enrolling)
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
• University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• Trinity Health - Ann Arbor Hospital — Ypsilanti, Michigan, United States (enrolling)
• Washington University in St. Louis — St Louis, Missouri, United States (enrolling)
• Rutgers New Jersey Medical School — Newark, New Jersey, United States (enrolling)
• University of New Mexico Health Sciences Center — Albuquerque, New Mexico, United States (enrolling)
• NYU Langone Health - Tisch Hospital — New York, New York, United States (enrolling)
• Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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