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NCT05591118PHASE3Recruiting

Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy

NYU Langone Health

Start Date

7/17/2023

Completion Date

8/4/2027

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 Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Anticoagulant Therapy

DEVICE

Catheter-Directed Therapy

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Conditions

Pulmonary Embolism

Locations

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 D.C., 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

St 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