Recruiting

Phase 3

Catheter-Directed TherapyPulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy

Sponsor:

NYU Langone Health

Code:

NCT05591118

Conditions

Pulmonary Embolism

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Anticoagulant Therapy

Catheter-Directed Therapy

Study Details

Brief 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.

Conditions

Pulmonary Embolism

Study ID

NCT05591118

Start date

Jul 17, 2023

Status verified date

May, 2026

Completion date

Aug 4, 2027

Anticipated

Primary completion date

Mar 29, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Catheter-Directed Therapy (CDT) plus Anticoagulation

Participants will receive CDT consisting of mechanical thrombectomy (MT) or intrathrombus catheter-directed thrombolysis (CDL) using FDA-cleared devices for pulmonary embolism (PE). The exact technique and devices used will be at the discretion of the endovascular physician, within parameters defined by the PE-TRACT Manual of Operations (MOP) and accepted standard care. Before and after CDT, patients will receive standard PE therapy as in the no-CDT Arm.

active comparator: No Catheter-Directed Therapy (No-CDT)

Standard anticoagulant therapy (FDA-approved regimen) for the treatment of PE.

Interventions

Anticoagulant Therapy

All subjects will receive anticoagulation for a minimum of 3 months.

Catheter-Directed Therapy

The endovascular physician can choose to use either mechanical thrombectomy (MT) using a device cleared by the FDA to treat PE or catheter-directed thrombolysis (CDL) using an infusion catheter cleared by the FDA to administer thrombolytic drugs for the treatment of PE

Primary outcome measure

Peak Oxygen Consumption (PVO2) [ Time Frame: Month 3 ]
New York Heart Association (NYHA) Functional Classification [ Time Frame: Month 12 ]
Incidence of Major Bleeding at Day 7 [ Time Frame: Up to Day 7 ]

Central Contacts and Locations

Central contacts

Sunil Rao

212-263-0456 Sunil.rao@nyulangone.org

Lei Lei

212-263-4189 Lei.lei@nyulangone.org

Locations

The University of Alabama At Birmingham

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Samuel McElwee, MD

205-975-7123 skmcelwee@uabmc.edu

Stanford Medicine

Recruiting

Palo Alto, California, United States, 94304

Contacts

Andrew Kesselman, MD

650-723-6855 ajk266@stanford.edu

UC Davis Health

Recruiting

Sacramento, California, United States, 95817

Contacts

Roger Goldman

916-734-8462 regoldman@ucdavis.edu

Scripps Memorial Hospital, La Jolla

Recruiting

San Diego, California, United States, 92121

Contacts

Daniel S. Jones, MD

215-908-5726 Jones.Daniel@scrippshealth.org

The Lundquist Institute

Recruiting

Torrance, California, United States, 90502

Contacts

Janine Vintch, MD

310-222-8200 jvintch@dhs.lacounty.gov

Christiana Care

Recruiting

Newark, Delaware, United States, 19718

Contacts

George Kimbiris, MD

302-733-5625 gkimbiris@christianacare.org

Principal Investigator:

George Kimbiris, MD

MedStar Health Research Institute

Recruiting

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

Contacts

Saher Sabri, MD

202-877-3657 saher.s.sabri@medstar.net

Baptist Health Miami Cardiac & Vascular Institute

Recruiting

Miami, Florida, United States, 33176

Contacts

Ripal Gandhi, MD

786-596-5990 gandhi@baptisthealth.net

Principal Investigator:

Ripal Gandhi, MD

University of South Florida/ Tampa General Hospital

Recruiting

Tampa, Florida, United States, 33606

Contacts

Glenn Hoots, MD

813-844-4570 hoots@usf.edu

Emory University School of Medicine

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Wissam Jabar, MD

404-686-7568 wissam.jaber@emory.edu

Principal Investigator:

Wissam Jabar, MD

University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Jonathan D. Paul, MD

773-834-1497 jpaul@medicine.bsd.uchicago.edu

Advocate Good Samaritan Hospital

Recruiting

Downers Grove, Illinois, United States, 60515

Contacts

Mahesh Raju, MD

630-719-4799 Mahesh.raju@aah.org

Principal Investigator:

Mahesh Raju, MD

Loyola University Chicago

Recruiting

Maywood, Illinois, United States, 60153

Contacts

Amir Darki, MD

708-216-4466 adarki@lumc.edu

Southern Illinois University School of Medicine

Recruiting

Springfield, Illinois, United States, 62781

Contacts

Abdul Moiz Hafiz

217-545-8000 ahafiz96@siumed.edu

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Kevin Doerschug

319-356-1445 kevin-doerschug@uiowa.edu

MaineHealth

Recruiting

Portland, Maine, United States, 04102

Contacts

Paul Kim, MD

207-956-6650 kimp9@spectrummg.com

Boston Medical Center

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

Ashvin Pande, MD

617-638-8703 Ashvin.pande@bmc.org

Principal Investigator:

Ashvin Pande, MD

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Brett Carroll, MD

617-667-8800 bcarrol2@bidmc.harvard.edu

Principal Investigator:

Brett Carroll, MD

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Minhajuddin Khaja, MD, MBA

734-936-4478 mkhaja@med.umich.edu

Trinity Health - Ann Arbor Hospital

Recruiting

Ypsilanti, Michigan, United States, 48197

Contacts

Hriday Shah, MD

734-712-8350 hriday.shah@aiarad.com

Washington University in St. Louis

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Pavan Kavali, MD

314-362-2900 pavan.kavali@wustl.edu

Rutgers New Jersey Medical School

Recruiting

Newark, New Jersey, United States, 07103

Contacts

Abhishek Kumar, M.D.

973-972-5188 kumarab@njms.rutgers.edu

University of New Mexico Health Sciences Center

Recruiting

Albuquerque, New Mexico, United States, 87131

Contacts

Carolina Ponce Orellana, MD

505-272-6020 CPonceOr@salud.unm.edu

NYU Langone Health - Tisch Hospital

Recruiting

New York, New York, United States, 10016

Contacts

Bedros Taslakian, MD, EBIR, FCIRSE

332-237-9866 bedros.taslakian@nyulangone.org

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Hooman Poor, MD

212-241-5656 hooman.poor@mountsinai.org

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10065

Contacts

Christopher M. Harnain, MD, MBA, RPVI

212.746.4635 cmh9017@med.cornell.edu

Promedica

Recruiting

Toledo, Ohio, United States, 43606

Contacts

Zakaria Assi, MD

419-291-4438 zassi@buckeye-express.com

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Khashayar Farsad, MD, PhD

503-494-7226 farsad@ohsu.edu

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Steven Pugliese, MD

215-614-1527 Steven.Pugliese@pennmedicine.upenn.edu

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Carin Gonsalves, MD

215-955-6609 Carin.Gonsalves@jefferson.edu

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Rabih A. Chaer, MD

412-802-3025 chaerra@upmc.edu

Main Line Healh

Recruiting

Wynnewood, Pennsylvania, United States, 19096

Contacts

Lee Greenspon, MD

610-642-3796 GreensponL@MLHS.ORG

Lifespan

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

DaeHee Kim, MD

401-444-5184 daehee_kim@brown.edu

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Kevin W. Dickey

843-792-5069 dickeyke@musc.edu

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Bela Patel, MD

713-500-6831 Bela.patel@uth.tmc.edu

Intermountain Health

Recruiting

Murray, Utah, United States, 84107

Contacts

Mark Dodson, MD

801-507-4603 Mark.Dodson@imail.org

University of Utah Health

Recruiting

Salt Lake City, Utah, United States, 84108

Contacts

Nathan Hatton, MD

801-581-5811 nathan.hatton@hsc.utah.edu

Sentara Health Research Center

Recruiting

Norfolk, Virginia, United States, 23507

Contacts

David Dexter, MD

757-388-5480 djdexte1@sentara.com

Carilion Clinic

Recruiting

Roanoke, Virginia, United States, 24014

Contacts

Joseph A. Hughes, M.D

540-981-7083 jahughes1@carilionclinic.org

Principal Investigator:

Joseph Hughes, MD

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Matthew J. Scheidt, MD

414-805-3125 mscheidt@mcw.edu

More Information

Sponsor

NYU Langone Health

Last update posted

May 18, 2026

Last verified

May, 2026

Keywords

Catheter-Directed Therapy (CDT)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-05-18.