Frontlight ResearchEarly access
Active, not recruitingPhase 3
Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy
Key facts
- Who runs it
- NYU Langone Health
- Where
- Albuquerque, Ann Arbor, Atlanta, Birmingham, Boston, Charleston, Chicago, Downers Grove, Houston, Iowa City, Maywood, Miami, Milwaukee, Murray, New York, Newark, Norfolk, Palo Alto, Philadelphia, Pittsburgh, Portland, Providence, Roanoke, Sacramento, Salt Lake City, San Diego, Springfield, St Louis, Tampa, Toledo, Torrance, Washington D.C., Wynnewood, and Ypsilanti, United StatesSee the 40 sites
- Trial code
- Status
- Active, not recruiting
- Phase
- Phase 3
- People taking part
- 500 people, planned
- Started
- 17 Jul 2023
- Expected to end
- 4 Aug 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Anticoagulant Therapy
- Catheter-Directed Therapy
- Record updated
- 28 October 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Pregnancy (positive urine or blood pregnancy test (a pregnancy test must be obtained within 7 days prior to randomization in people of childbearing potential))
- 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 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
- Allergy to heparin or history of Heparin-Induced Thrombocytopenia (HIT)
- Irreversible INR > 3
- Irreversible Thrombocytopenia (Platelets < 50,000/microliter)
- Creatinine > 2.0 mg/dl
- Hemoglobin < 7.0 g/dl
- Age < 18 years
- Symptom duration > 14 days for the current PE episode
- Life expectancy < 1 year
- Unable or unwilling to provide informed consent
- Major contraindication or unsuitability for all CDT methods available at the Clinical Center
Where in United States
- University of New Mexico Health Sciences CenterAlbuquerque, United States
- University of MichiganAnn Arbor, United States
- Emory University School of MedicineAtlanta, United States
- The University of Alabama at BirminghamBirmingham, United States
- Beth Israel Deaconess Medical CenterBoston, United States
- Boston Medical CenterBoston, United States
- Medical University of South CarolinaCharleston, United States
- University of Chicago Medical CenterChicago, United States
- Advocate Good Samaritan HospitalDowners Grove, United States
- The University of Texas Health Science Center at HoustonHouston, United States
- University of IowaIowa City, United States
- Loyola University ChicagoMaywood, United States
- Baptist Health Miami Cardiac & Vascular InstituteMiami, United States
- Medical College of WisconsinMilwaukee, United States
- Intermountain HealthMurray, United States
- Icahn School of Medicine at Mount SinaiNew York, United States
- NYU Langone Health - Tisch HospitalNew York, United States
- Weill Cornell MedicineNew York, United States
- Christiana CareNewark, United States
- Rutgers New Jersey Medical SchoolNewark, United States
- Sentara Health Research CenterNorfolk, United States
- Stanford MedicinePalo Alto, United States
- Thomas Jefferson UniversityPhiladelphia, United States
- University of PennsylvaniaPhiladelphia, United States
- University of Pittsburgh Medical CenterPittsburgh, United States
- MaineHealthPortland, United States
- Oregon Health Science UniversityPortland, United States
- LifespanProvidence, United States
- Carilion ClinicRoanoke, United States
- UC Davis HealthSacramento, United States
- University Of Utah HealthSalt Lake City, United States
- Scripps Memorial Hospital La JollaSan Diego, United States
- Southern Illinois University School of MedicineSpringfield, United States
- Washington University in St. LouisSt Louis, United States
- University of South Florida (Tampa General Hospital)Tampa, United States
- ProMedicaToledo, United States
- The Lundquist InstituteTorrance, United States
- Medstar Health Research InstituteWashington D.C., United States
- Main Line HealhWynnewood, United States
- Trinity Health Ann Arbor HospitalYpsilanti, United States
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Catheter-Directed Therapy (CDT) plus AnticoagulationTreatment being tested
Participants will receive CDT consisting of mechanical thrombectomy (MT) or intrathrombus catheter-directed thrombolysis (CDL) using FDA-cleared devices for pulmonary embolism (PE). The exact technique and devices used will be at the discretion of the endovascular physician, within parameters defined by the PE-TRACT Manual of Operations (MOP) and accepted standard care. Before and after CDT, patients will receive standard PE therapy as in the no-CDT Arm.
Treatment: Anticoagulant Therapy and Catheter-Directed Therapy
- No Catheter-Directed Therapy (No-CDT)Existing treatment, for comparison
Standard anticoagulant therapy (FDA-approved regimen) for the treatment of PE.
Treatment: Anticoagulant Therapy
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 28 October 2026