Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy

NCT05591118 · tracked via the Priya Life Science Israel tracker

Sponsor

NYU Langone Health

Phase

Phase 3

Started

2023-07-17

Last updated

2026-05-18

Condition(s) studied

Pulmonary Embolism

Investigational drug(s) / intervention(s)

Anticoagulant TherapyCatheter-Directed Therapy

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

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Peak Oxygen Consumption (PVO2) — Month 3
PVO2 measured during cardiopulmonary exercise test (CPET).
New York Heart Association (NYHA) Functional Classification — Month 12
The NYHA classifies the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity; the limitations/symptoms are in regards to normal breathing and varying degrees in shortness of breath and or angina pain: * Class I - No symptoms and no limitation with ordinary physical activity. * Class II - Mild symptoms and slight limitation during ordinary activity. * Class III - Moderate limitation in activity (even less than ordinary) due to symptoms. * Class IV - Symptoms occur at rest and severe limitation with any physical activity. * Class V - Dead.
Incidence of Major Bleeding at Day 7 — Up to Day 7
International Society on Thrombosis and Haemostasis (ISTH) definition of "Major Bleeding" to be used. Per ISTH, Major Bleeding defined as: 1. Fatal bleeding, AND/OR; 2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, AND/OR; 3. Bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells.

Trial sites (40)

Facility	City	Region	Status
The University of Alabama At Birmingham	Birmingham	Alabama	Recruiting
Stanford Medicine	Palo Alto	California	Recruiting
UC Davis Health	Sacramento	California	Recruiting
Scripps Memorial Hospital, La Jolla	San Diego	California	Recruiting
The Lundquist Institute	Torrance	California	Recruiting
Christiana Care	Newark	Delaware	Recruiting
MedStar Health Research Institute	Washington D.C.	District of Columbia	Recruiting
Baptist Health Miami Cardiac & Vascular Institute	Miami	Florida	Recruiting
University of South Florida/ Tampa General Hospital	Tampa	Florida	Recruiting
Emory University School of Medicine	Atlanta	Georgia	Recruiting
University of Chicago Medical Center	Chicago	Illinois	Recruiting
Advocate Good Samaritan Hospital	Downers Grove	Illinois	Recruiting
Loyola University Chicago	Maywood	Illinois	Recruiting
Southern Illinois University School of Medicine	Springfield	Illinois	Recruiting
University of Iowa	Iowa City	Iowa	Recruiting
MaineHealth	Portland	Maine	Recruiting
Boston Medical Center	Boston	Massachusetts	Recruiting
Beth Israel Deaconess Medical Center	Boston	Massachusetts	Recruiting
University of Michigan	Ann Arbor	Michigan	Recruiting
Trinity Health - Ann Arbor Hospital	Ypsilanti	Michigan	Recruiting
Washington University in St. Louis	St Louis	Missouri	Recruiting
Rutgers New Jersey Medical School	Newark	New Jersey	Recruiting
University of New Mexico Health Sciences Center	Albuquerque	New Mexico	Recruiting
NYU Langone Health - Tisch Hospital	New York	New York	Recruiting
Icahn School of Medicine at Mount Sinai	New York	New York	Recruiting
Weill Cornell Medicine	New York	New York	Recruiting
Promedica	Toledo	Ohio	Recruiting
Oregon Health & Science University	Portland	Oregon	Recruiting
University of Pennsylvania	Philadelphia	Pennsylvania	Recruiting
Thomas Jefferson University	Philadelphia	Pennsylvania	Recruiting
University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	Recruiting
Main Line Healh	Wynnewood	Pennsylvania	Recruiting
Lifespan	Providence	Rhode Island	Recruiting
Medical University of South Carolina	Charleston	South Carolina	Recruiting
The University of Texas Health Science Center at Houston	Houston	Texas	Recruiting
Intermountain Health	Murray	Utah	Recruiting
University of Utah Health	Salt Lake City	Utah	Recruiting
Sentara Health Research Center	Norfolk	Virginia	Recruiting
Carilion Clinic	Roanoke	Virginia	Recruiting
Medical College of Wisconsin	Milwaukee	Wisconsin	Recruiting

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Other trials for the same condition

Ultrasound-facilitated, Catheter-directed, Thrombolysis in Intermediate-high Risk Pulmonary Embolism Active, not recruiting

The RAPID - PE Study: RESCUE Advanced Protocol for the Treatment of Pulmonary Embolism Recruiting

Incidental Discovery of Pulmonary Emboli Via CT Scan: Impact of Detections on Patient Care and Resulting Complications Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05591118 on ClinicalTrials.gov ↗ ← All trials in Israel