Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy
PE-TRACT
1 other identifier
interventional
500
1 country
40
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2023
Typical duration for phase_3
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2022
CompletedFirst Posted
Study publicly available on registry
October 24, 2022
CompletedStudy Start
First participant enrolled
July 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 29, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 4, 2027
May 18, 2026
May 1, 2026
3.7 years
October 18, 2022
May 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Peak Oxygen Consumption (PVO2)
PVO2 measured during cardiopulmonary exercise test (CPET).
Month 3
New York Heart Association (NYHA) Functional Classification
The NYHA classifies the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity; the limitations/symptoms are in regards to normal breathing and varying degrees in shortness of breath and or angina pain: * Class I - No symptoms and no limitation with ordinary physical activity. * Class II - Mild symptoms and slight limitation during ordinary activity. * Class III - Moderate limitation in activity (even less than ordinary) due to symptoms. * Class IV - Symptoms occur at rest and severe limitation with any physical activity. * Class V - Dead.
Month 12
Incidence of Major Bleeding at Day 7
International Society on Thrombosis and Haemostasis (ISTH) definition of "Major Bleeding" to be used. Per ISTH, Major Bleeding defined as: 1. Fatal bleeding, AND/OR; 2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, AND/OR; 3. Bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells.
Up to Day 7
Secondary Outcomes (3)
Six-Minute Walk Distance (6MWD)
Month 12
Short-Form Health Survey-36 (SF-36) Score
Month 12
Incidence of Clinical Deterioration (Fatal and Non-Fatal) at Day 7
Up to Day 7
Study Arms (2)
Catheter-Directed Therapy (CDT) plus Anticoagulation
EXPERIMENTALParticipants 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.
No Catheter-Directed Therapy (No-CDT)
ACTIVE COMPARATORStandard anticoagulant therapy (FDA-approved regimen) for the treatment of PE.
Interventions
All subjects will receive anticoagulation for a minimum of 3 months.
The endovascular physician can choose to use either mechanical thrombectomy (MT) using a device cleared by the FDA to treat PE or catheter-directed thrombolysis (CDL) using an infusion catheter cleared by the FDA to administer thrombolytic drugs for the treatment of PE
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
The University of Alabama At Birmingham
Birmingham, Alabama, 35233, United States
Stanford Medicine
Palo Alto, California, 94304, United States
UC Davis Health
Sacramento, California, 95817, United States
Scripps Memorial Hospital, La Jolla
San Diego, California, 92121, United States
The Lundquist Institute
Torrance, California, 90502, United States
Christiana Care
Newark, Delaware, 19718, United States
MedStar Health Research Institute
Washington D.C., District of Columbia, 20010, United States
Baptist Health Miami Cardiac & Vascular Institute
Miami, Florida, 33176, United States
University of South Florida/ Tampa General Hospital
Tampa, Florida, 33606, United States
Emory University School of Medicine
Atlanta, Georgia, 30308, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515, United States
Loyola University Chicago
Maywood, Illinois, 60153, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62781, United States
University of Iowa
Iowa City, Iowa, 52242, United States
MaineHealth
Portland, Maine, 04102, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Trinity Health - Ann Arbor Hospital
Ypsilanti, Michigan, 48197, United States
Washington University in St. Louis
St Louis, Missouri, 63110, United States
Rutgers New Jersey Medical School
Newark, New Jersey, 07103, United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87131, United States
NYU Langone Health - Tisch Hospital
New York, New York, 10016, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Weill Cornell Medicine
New York, New York, 10065, United States
Promedica
Toledo, Ohio, 43606, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232, United States
Main Line Healh
Wynnewood, Pennsylvania, 19096, United States
Lifespan
Providence, Rhode Island, 02903, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Intermountain Health
Murray, Utah, 84107, United States
University of Utah Health
Salt Lake City, Utah, 84108, United States
Sentara Health Research Center
Norfolk, Virginia, 23507, United States
Carilion Clinic
Roanoke, Virginia, 24014, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
Sista AK, Troxel AB, Tarpey T, Parpia S, Goldhaber SZ, Stringer WW, Magnuson EA, Cohen DJ, Kahn SR, Rao SV, Morris TA, Goldfeld KS, Vedantham S. Rationale and design of the PE-TRACT trial: A multicenter randomized trial to evaluate catheter-directed therapy for the treatment of intermediate-risk pulmonary embolism. Am Heart J. 2025 Mar;281:112-122. doi: 10.1016/j.ahj.2024.11.016. Epub 2024 Dec 3.
PMID: 39638275DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sunil Rao, MD
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2022
First Posted
October 24, 2022
Study Start
July 17, 2023
Primary Completion (Estimated)
March 29, 2027
Study Completion (Estimated)
August 4, 2027
Last Updated
May 18, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to aks9010@med.cornell.edu. To gain access, data requestors will need to sign a data access agreement.
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: aks9010@med.cornell.edu.The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.