Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy

Description

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.

Conditions

Pulmonary Embolism

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Study Overview

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Study Details

Study overview

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.

Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy

Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy

Condition
Pulmonary Embolism
Intervention / Treatment

-

Contacts and Locations

Birmingham

The University of Alabama At Birmingham, Birmingham, Alabama, United States, 35233

Palo Alto

Stanford Medicine, Palo Alto, California, United States, 94304

Sacramento

UC Davis Health, Sacramento, California, United States, 95817

San Diego

Scripps Memorial Hospital, La Jolla, San Diego, California, United States, 92121

Torrance

The Lundquist Institute, Torrance, California, United States, 90502

Newark

Christiana Care, Newark, Delaware, United States, 19718

Washington

MedStar Health Research Institute, Washington, District of Columbia, United States, 20010

Miami

Baptist Health Miami Cardiac & Vascular Institute, Miami, Florida, United States, 33176

Tampa

University of South Florida/ Tampa General Hospital, Tampa, Florida, United States, 33606

Atlanta

Emory University School of Medicine, Atlanta, Georgia, United States, 30308

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

NYU Langone Health,

Akhilesh Sista, MD, PRINCIPAL_INVESTIGATOR, Weill Cornell School of Medicine

Study Record Dates

2028-01