RECRUITING

Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy

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Conditions

Pulmonary EmbolismCatheter-Directed Therapy (CDT)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy

Quick Facts

Study Start:2023-07-17
Study Completion:2028-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05591118

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Symptomatic PE diagnosed by contrast-enhanced CT angiography with involvement of a main or lobar pulmonary artery branch; and
  2. 2. Right ventricular (RV) dilation as defined by the presence of an RV/Left ventricular ratio \> 1 on CT angiography
  1. 1. Age \< 18 years
  2. 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. 3. Symptom duration \> 14 days for the current PE episode
  4. 4. Irreversible INR \> 3
  5. 5. Irreversible Thrombocytopenia (Platelets \< 50,000/microliter)
  6. 6. Creatinine \> 2.0 mg/dl
  7. 7. Hemoglobin \< 7.0 g/dl
  8. 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. 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. 10. Life expectancy \< 1 year
  11. 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. 12. Allergy to heparin or history of Heparin-Induced Thrombocytopenia (HIT)
  13. 13. Unable or unwilling to provide informed consent
  14. 14. Major contraindication or unsuitability for all CDT methods available at the Clinical Center

Contacts and Locations

Study Contact

Akhilesh Sista
CONTACT
212-263-5898
aks9010@med.cornell.edu
Sunil Rao
CONTACT
212-263-0456
Sunil.rao@nyulangone.org

Principal Investigator

Akhilesh Sista, MD
PRINCIPAL_INVESTIGATOR
Weill Cornell School of Medicine

Study Locations (Sites)

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, 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
Saint 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

Collaborators and Investigators

Sponsor: NYU Langone Health

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

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 Registration Dates

Study Start Date2023-07-17
Study Completion Date2028-01

Study Record Updates

Study Start Date2023-07-17
Study Completion Date2028-01

Terms related to this study

Keywords Provided by Researchers

  • Catheter-Directed Therapy (CDT)

Additional Relevant MeSH Terms

  • Pulmonary Embolism