🏛️ Verified NIH Record • Updated 2026-05-15
Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy (NCT05591118)
🟢 Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: NYU Langone Health
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (2 items) and avoid the listed exclusions (15 items).
Location: The University of Alabama At Birmingham — Birmingham, Alabama
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
- Chronic inability to independently walk prior to the current PE episode (e.g. wheelchair dependent, walker or cane dependent, paraplegic, and/or bed-bound)
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (40 Sites)
- The University of Alabama At Birmingham — Birmingham, Alabama
- Stanford Medicine — Palo Alto, California
- UC Davis Health — Sacramento, California
- Scripps Memorial Hospital, La Jolla — San Diego, California
- The Lundquist Institute — Torrance, California
- Christiana Care — Newark, Delaware
- MedStar Health Research Institute — Washington D.C., District of Columbia
- Baptist Health Miami Cardiac & Vascular Institute — Miami, Florida
- University of South Florida/ Tampa General Hospital — Tampa, Florida
- Emory University School of Medicine — Atlanta, Georgia
- University of Chicago Medical Center — Chicago, Illinois
- Advocate Good Samaritan Hospital — Downers Grove, Illinois
- Loyola University Chicago — Maywood, Illinois
- Southern Illinois University School of Medicine — Springfield, Illinois
- University of Iowa — Iowa City, Iowa
- MaineHealth — Portland, Maine
- Boston Medical Center — Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts
- University of Michigan — Ann Arbor, Michigan
- Trinity Health - Ann Arbor Hospital — Ypsilanti, Michigan
- Washington University in St. Louis — St Louis, Missouri
- Rutgers New Jersey Medical School — Newark, New Jersey
- University of New Mexico Health Sciences Center — Albuquerque, New Mexico
- NYU Langone Health - Tisch Hospital — New York, New York
- Icahn School of Medicine at Mount Sinai — New York, New York
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.