Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy

Last updated: April 22, 2025
Sponsor: NYU Langone Health
Overall Status: Active - Recruiting

Phase

3

Condition

Claudication

Occlusions

Deep Vein Thrombosis

Treatment

Anticoagulant Therapy

Catheter-Directed Therapy

Clinical Study ID

NCT05591118
22-01272
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Symptomatic PE diagnosed by contrast-enhanced CT angiography with involvement of amain or lobar pulmonary artery branch; and

  2. Right ventricular (RV) dilation as defined by the presence of an RV/Left ventricularratio > 1 on CT angiography

Exclusion

Exclusion Criteria:

  1. Age < 18 years

  2. Systolic blood pressure < 90 mmHg for >15 consecutive minutes or > 40 mmHg drop frombaseline, 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 obtainedwithin 7 days prior to randomization in people of childbearing potential))

  9. Allergy or hypersensitivity to Recombinant Tissue Plasminogen Activator (rt-PA), oriodinated contrast, except for mild-moderate contrast allergies for which steroidpre-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 theClinical Center

Study Design

Total Participants: 500
Treatment Group(s): 2
Primary Treatment: Anticoagulant Therapy
Phase: 3
Study Start date:
July 17, 2023
Estimated Completion Date:
January 31, 2028

Connect with a study center

  • The University of Alabama At Birmingham

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • Stanford Medicine

    Palo Alto, California 94304
    United States

    Active - Recruiting

  • UC Davis Health

    Sacramento, California 95817
    United States

    Active - Recruiting

  • Scripps Memorial Hospital, La Jolla

    San Diego, California 92121
    United States

    Active - Recruiting

  • The Lundquist Institute

    Torrance, California 90502
    United States

    Active - Recruiting

  • Christiana Care

    Newark, Delaware 19718
    United States

    Active - Recruiting

  • Christiana Care Health System

    Newark, Delaware 19713
    United States

    Active - Recruiting

  • MedStar Health Research Institute

    Washington, District of Columbia 20010
    United States

    Active - Recruiting

  • Baptist Health Miami Cardiac & Vascular Institute

    Miami, Florida 33176
    United States

    Active - Recruiting

  • Baptist Hospital of Miami

    Miami, Florida 33143
    United States

    Active - Recruiting

  • University of South Florida/ Tampa General Hospital

    Tampa, Florida 33606
    United States

    Active - Recruiting

  • Emory University

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Emory University School of Medicine

    Atlanta, Georgia 30308
    United States

    Active - Recruiting

  • University of Chicago Medical Center

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Advocate Aurora Health

    Downers Grove, Illinois 60515
    United States

    Active - Recruiting

  • Advocate Good Samaritan Hospital

    Downers Grove, Illinois 60515
    United States

    Active - Recruiting

  • Loyola University Chicago

    Maywood, Illinois 60153
    United States

    Active - Recruiting

  • Southern Illinois University School of Medicine

    Springfield, Illinois 62781
    United States

    Active - Recruiting

  • University of Iowa

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • MaineHealth

    Portland, Maine 04102
    United States

    Active - Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Boston Medical Center

    Boston, Massachusetts 02118
    United States

    Active - Recruiting

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Trinity Health - Ann Arbor Hospital

    Ypsilanti, Michigan 48197
    United States

    Active - Recruiting

  • Washington University in St. Louis

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • Rutgers New Jersey Medical School

    Newark, New Jersey 07103
    United States

    Active - Recruiting

  • University of New Mexico Health Sciences Center

    Albuquerque, New Mexico 87131
    United States

    Active - Recruiting

  • Columbia University

    New York, New York 10027
    United States

    Site Not Available

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Active - Recruiting

  • NYU Langone Health - Tisch Hospital

    New York, New York 10016
    United States

    Active - Recruiting

  • Weill Cornell Medicine

    New York, New York 10065
    United States

    Active - Recruiting

  • Cone Health

    Greensboro, North Carolina 27403
    United States

    Site Not Available

  • Promedica

    Toledo, Ohio 43606
    United States

    Active - Recruiting

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15232
    United States

    Active - Recruiting

  • Main Line Healh

    Wynnewood, Pennsylvania 19096
    United States

    Active - Recruiting

  • Lifespan

    Providence, Rhode Island 02903
    United States

    Active - Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • The University of Texas Health Science Center at Houston

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Intermountain Health

    Murray, Utah 84107
    United States

    Active - Recruiting

  • University of Utah Health

    Salt Lake City, Utah 84108
    United States

    Active - Recruiting

  • Sentara Health Research Center

    Norfolk, Virginia 23507
    United States

    Active - Recruiting

  • Carilion Clinic

    Roanoke, Virginia 24014
    United States

    Active - Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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