Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy (PE-TRACT)

May 15, 2026 updated by: NYU Langone Health
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • The University of Alabama at Birmingham
        • Contact:
    • California
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford Medicine
        • Contact:
      • Sacramento, California, United States, 95817
        • Recruiting
        • UC Davis Health
        • Contact:
      • San Diego, California, United States, 92121
      • Torrance, California, United States, 90502
        • Recruiting
        • The Lundquist Institute
        • Contact:
    • Delaware
      • Newark, Delaware, United States, 19718
        • Recruiting
        • Christiana Care
        • Principal Investigator:
          • George Kimbiris, MD
        • Contact:
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Recruiting
        • MedStar Health Research Institute
        • Contact:
    • Florida
      • Miami, Florida, United States, 33176
        • Recruiting
        • Baptist Health Miami Cardiac & Vascular Institute
        • Principal Investigator:
          • Ripal Gandhi, MD
        • Contact:
      • Tampa, Florida, United States, 33606
        • Recruiting
        • University of South Florida/ Tampa General Hospital
        • Contact:
          • Glenn Hoots, MD
          • Phone Number: 813-844-4570
          • Email: hoots@usf.edu
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University School of Medicine
        • Principal Investigator:
          • Wissam Jabar, MD
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60637
      • Downers Grove, Illinois, United States, 60515
        • Recruiting
        • Advocate Good Samaritan Hospital
        • Principal Investigator:
          • Mahesh Raju, MD
        • Contact:
      • Maywood, Illinois, United States, 60153
        • Recruiting
        • Loyola University Chicago
        • Contact:
      • Springfield, Illinois, United States, 62781
        • Recruiting
        • Southern Illinois University School of Medicine
        • Contact:
    • Iowa
      • Iowa City, Iowa, United States, 52242
    • Maine
      • Portland, Maine, United States, 04102
        • Recruiting
        • MaineHealth
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Principal Investigator:
          • Brett Carroll, MD
        • Contact:
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Boston Medical Center
        • Principal Investigator:
          • Ashvin Pande, MD
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Contact:
      • Ypsilanti, Michigan, United States, 48197
        • Recruiting
        • Trinity Health - Ann Arbor Hospital
        • Contact:
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University in St. Louis
        • Contact:
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • Recruiting
        • Rutgers New Jersey Medical School
        • Contact:
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Recruiting
        • University of New Mexico Health Sciences Center
        • Contact:
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Weill Cornell Medicine
        • Contact:
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai
        • Contact:
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Health - Tisch Hospital
        • Contact:
    • Ohio
      • Toledo, Ohio, United States, 43606
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
        • Contact:
          • Khashayar Farsad, MD, PhD
          • Phone Number: 503-494-7226
          • Email: farsad@ohsu.edu
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia, Pennsylvania, United States, 19107
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • University of Pittsburgh Medical Center
        • Contact:
      • Wynnewood, Pennsylvania, United States, 19096
        • Recruiting
        • Main Line Healh
        • Contact:
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Lifespan
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas Health Science Center at Houston
        • Contact:
    • Utah
      • Murray, Utah, United States, 84107
        • Recruiting
        • Intermountain Health
        • Contact:
      • Salt Lake City, Utah, United States, 84108
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Sentara Health Research Center
        • Contact:
      • Roanoke, Virginia, United States, 24014
        • Recruiting
        • Carilion Clinic
        • Principal Investigator:
          • Joseph Hughes, MD
        • Contact:
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Symptomatic PE diagnosed by contrast-enhanced CT angiography with involvement of a main or lobar pulmonary artery branch; and
  2. Right ventricular (RV) dilation as defined by the presence of an RV/Left ventricular ratio > 1 on CT angiography

Exclusion Criteria:

  1. Age < 18 years
  2. 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.
  3. Symptom duration > 14 days for the current PE episode
  4. Irreversible INR > 3
  5. Irreversible Thrombocytopenia (Platelets < 50,000/microliter)
  6. Creatinine > 2.0 mg/dl
  7. Hemoglobin < 7.0 g/dl
  8. Pregnancy (positive urine or blood pregnancy test (a pregnancy test must be obtained within 7 days prior to randomization in people of childbearing potential))
  9. 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
  10. Life expectancy < 1 year
  11. Chronic inability to independently walk prior to the current PE episode (e.g. wheelchair dependent, walker or cane dependent, paraplegic, and/or bed-bound)
  12. Allergy to heparin or history of Heparin-Induced Thrombocytopenia (HIT)
  13. Unable or unwilling to provide informed consent
  14. Major contraindication or unsuitability for all CDT methods available at the Clinical Center

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Catheter-Directed Therapy (CDT) plus Anticoagulation
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.
Drug: Anticoagulant Therapy
All subjects will receive anticoagulation for a minimum of 3 months.
Other Names:
  • Activase (alteplase)
Device: Catheter-Directed Therapy
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
Active Comparator: No Catheter-Directed Therapy (No-CDT)
Standard anticoagulant therapy (FDA-approved regimen) for the treatment of PE.
Drug: Anticoagulant Therapy
All subjects will receive anticoagulation for a minimum of 3 months.
Other Names:
  • Activase (alteplase)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak Oxygen Consumption (PVO2)
Time Frame: Month 3
PVO2 measured during cardiopulmonary exercise test (CPET).
Month 3
New York Heart Association (NYHA) Functional Classification
Time Frame: Month 12

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
Time Frame: Up to 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Six-Minute Walk Distance (6MWD)
Time Frame: Month 12
Month 12
Short-Form Health Survey-36 (SF-36) Score
Time Frame: Month 12
36-item questionnaire assessing general health. It measures 8 dimensions of health status: social function, physical function, emotional role, physical role, mental health, vitality, physical pain, and general health. Scores range from 0 (worst health status) to 100 (best health status).
Month 12
Incidence of Clinical Deterioration (Fatal and Non-Fatal) at Day 7
Time Frame: Up to Day 7
Clinical deterioration defined as hemodynamic decompensation or respiratory decompensation requiring endotracheal intubation.
Up to Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Sunil Rao, MD, NYU Langone Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2023

Primary Completion (Estimated)

March 29, 2027

Study Completion (Estimated)

August 4, 2027

Study Registration Dates

First Submitted

October 18, 2022

First Submitted That Met QC Criteria

October 18, 2022

First Posted (Actual)

October 24, 2022

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 15, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-01272

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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