Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT05591118

Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy

Led by NYU Langone Health · Updated on 2026-05-01

500

Participants Needed

40

Research Sites

205 weeks

Total Duration

On this page

Sponsors

N

NYU Langone Health

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Symptomatic pulmonary embolism diagnosed by contrast-enhanced CT angiography involving a main or lobar pulmonary artery branch
  • Right ventricular enlargement defined by an RV/Left ventricular ratio greater than 1 on CT angiography
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Low blood pressure below 90 mmHg for over 15 minutes or significant drop from baseline, or need for blood pressure support medications within 1 hour before assessment
  • Symptoms lasting more than 14 days for the current pulmonary embolism
  • Irreversible high INR greater than 3
  • Irreversible low platelet count below 50,000/microliter
  • Kidney dysfunction with creatinine over 2.0 mg/dl
  • Low hemoglobin below 7.0 g/dl
  • Pregnancy confirmed by urine or blood test within 7 days prior to randomization
  • Allergy or sensitivity to recombinant tissue plasminogen activator or iodinated contrast, except mild to moderate contrast allergies treatable with steroids
  • Life expectancy less than 1 year
  • Chronic inability to walk independently before the current pulmonary embolism episode
  • Allergy to heparin or history of heparin-induced thrombocytopenia
  • Unable or unwilling to provide informed consent
  • Major contraindications or unsuitability for all catheter-directed therapy methods available at the study center

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 40 locations

1

The University of Alabama At Birmingham

Birmingham, Alabama, United States, 35233

Actively Recruiting

2

Stanford Medicine

Palo Alto, California, United States, 94304

Actively Recruiting

3

UC Davis Health

Sacramento, California, United States, 95817

Actively Recruiting

4

Scripps Memorial Hospital, La Jolla

San Diego, California, United States, 92121

Actively Recruiting

5

The Lundquist Institute

Torrance, California, United States, 90502

Actively Recruiting

6

Christiana Care

Newark, Delaware, United States, 19718

Actively Recruiting

7

MedStar Health Research Institute

Washington D.C., District of Columbia, United States, 20010

Actively Recruiting

8

Baptist Health Miami Cardiac & Vascular Institute

Miami, Florida, United States, 33176

Actively Recruiting

9

University of South Florida/ Tampa General Hospital

Tampa, Florida, United States, 33606

Actively Recruiting

10

Emory University School of Medicine

Atlanta, Georgia, United States, 30308

Actively Recruiting

11

University of Chicago Medical Center

Chicago, Illinois, United States, 60637

Actively Recruiting

12

Advocate Good Samaritan Hospital

Downers Grove, Illinois, United States, 60515

Actively Recruiting

13

Loyola University Chicago

Maywood, Illinois, United States, 60153

Actively Recruiting

14

Southern Illinois University School of Medicine

Springfield, Illinois, United States, 62781

Actively Recruiting

15

University of Iowa

Iowa City, Iowa, United States, 52242

Actively Recruiting

16

MaineHealth

Portland, Maine, United States, 04102

Actively Recruiting

17

Boston Medical Center

Boston, Massachusetts, United States, 02118

Actively Recruiting

18

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Actively Recruiting

19

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

20

Trinity Health - Ann Arbor Hospital

Ypsilanti, Michigan, United States, 48197

Actively Recruiting

21

Washington University in St. Louis

St Louis, Missouri, United States, 63110

Actively Recruiting

22

Rutgers New Jersey Medical School

Newark, New Jersey, United States, 07103

Actively Recruiting

23

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, United States, 87131

Actively Recruiting

24

NYU Langone Health - Tisch Hospital

New York, New York, United States, 10016

Actively Recruiting

25

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

Actively Recruiting

26

Weill Cornell Medicine

New York, New York, United States, 10065

Actively Recruiting

27

Promedica

Toledo, Ohio, United States, 43606

Actively Recruiting

28

Oregon Health & Science University

Portland, Oregon, United States, 97239

Actively Recruiting

29

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

30

Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107

Actively Recruiting

31

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15232

Actively Recruiting

32

Main Line Healh

Wynnewood, Pennsylvania, United States, 19096

Actively Recruiting

33

Lifespan

Providence, Rhode Island, United States, 02903

Actively Recruiting

34

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Actively Recruiting

35

The University of Texas Health Science Center at Houston

Houston, Texas, United States, 77030

Actively Recruiting

36

Intermountain Health

Murray, Utah, United States, 84107

Actively Recruiting

37

University of Utah Health

Salt Lake City, Utah, United States, 84108

Actively Recruiting

38

Sentara Health Research Center

Norfolk, Virginia, United States, 23507

Actively Recruiting

39

Carilion Clinic

Roanoke, Virginia, United States, 24014

Actively Recruiting

40

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

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Research Team

S

Sunil Rao

CONTACT

L

Lei Lei

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy | DecenTrialz