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Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy

RecruitingPhase 3

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: NYU Langone Health · Participants: 500 · Started: Jul 17, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05591118

Locations in the U.S.

AlabamaThe University of Alabama At Birmingham, Birmingham
CaliforniaStanford Medicine, Palo Alto
UC Davis Health, Sacramento
Scripps Memorial Hospital, La Jolla, San Diego
The Lundquist Institute, Torrance
DelawareChristiana Care, Newark
District of ColumbiaMedStar Health Research Institute, Washington D.C.
FloridaBaptist Health Miami Cardiac & Vascular Institute, Miami
University of South Florida/ Tampa General Hospital, Tampa
GeorgiaEmory University School of Medicine, Atlanta
IllinoisUniversity of Chicago Medical Center, Chicago
Advocate Good Samaritan Hospital, Downers Grove
Loyola University Chicago, Maywood
Southern Illinois University School of Medicine, Springfield
IowaUniversity of Iowa, Iowa City
MaineMaineHealth, Portland
MassachusettsBeth Israel Deaconess Medical Center, Boston
Boston Medical Center, Boston
MichiganUniversity of Michigan, Ann Arbor
Trinity Health - Ann Arbor Hospital, Ypsilanti
MissouriWashington University in St. Louis, St Louis
New JerseyRutgers New Jersey Medical School, Newark
New MexicoUniversity of New Mexico Health Sciences Center, Albuquerque
New YorkIcahn School of Medicine at Mount Sinai, New York
NYU Langone Health - Tisch Hospital, New York
Weill Cornell Medicine, New York
OhioPromedica, Toledo
OregonOregon Health & Science University, Portland
PennsylvaniaThomas Jefferson University, Philadelphia
University of Pennsylvania, Philadelphia
University of Pittsburgh Medical Center, Pittsburgh
Main Line Healh, Wynnewood
Rhode IslandLifespan, Providence
South CarolinaMedical University of South Carolina, Charleston
TexasThe University of Texas Health Science Center at Houston, Houston
UtahIntermountain Health, Murray
University of Utah Health, Salt Lake City
VirginiaSentara Health Research Center, Norfolk
Carilion Clinic, Roanoke
WisconsinMedical College of Wisconsin, Milwaukee

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.