Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy
- Conditions
- Pulmonary Embolism
- Interventions
- Drug: Anticoagulant TherapyDevice: Catheter-Directed Therapy
- Registration Number
- NCT05591118
- Lead Sponsor
- NYU Langone Health
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- Symptomatic PE diagnosed by contrast-enhanced CT angiography with involvement of a main or lobar pulmonary artery branch; and
- Right ventricular (RV) dilation as defined by the presence of an RV/Left ventricular ratio > 1 on CT angiography
- Age < 18 years
- 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.
- Symptom duration > 14 days for the current PE episode
- Irreversible INR > 3
- Irreversible Thrombocytopenia (Platelets < 50,000/microliter)
- Creatinine > 2.0 mg/dl
- Hemoglobin < 7.0 g/dl
- Pregnancy (positive urine or blood pregnancy test (a pregnancy test must be obtained within 7 days prior to randomization in people of childbearing potential))
- 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
- Life expectancy < 1 year
- Chronic inability to independently walk prior to the current PE episode (e.g. wheelchair dependent, walker or cane dependent, paraplegic, and/or bed-bound)
- Allergy to heparin or history of Heparin-Induced Thrombocytopenia (HIT)
- Unable or unwilling to provide informed consent
- Major contraindication or unsuitability for all CDT methods available at the Clinical Center
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description No Catheter-Directed Therapy (No-CDT) Anticoagulant Therapy Standard anticoagulant therapy (FDA-approved regimen) for the treatment of PE. Catheter-Directed Therapy (CDT) plus Anticoagulation Anticoagulant Therapy 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. Catheter-Directed Therapy (CDT) plus Anticoagulation Catheter-Directed Therapy 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.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Six-Minute Walk Distance (6MWD) Month 12 Incidence of Clinical Deterioration (Fatal and Non-Fatal) at Day 7 Up to Day 7 Clinical deterioration defined as hemodynamic decompensation or respiratory decompensation requiring endotracheal intubation.
Short-Form Health Survey-36 (SF-36) Score Month 12 36-item questionnaire assessing general health. It measures 8 dimensions of health status: social function, physical function, emotional role, physical role, mental health, vitality, physical pain, and general health. Scores range from 0 (worst health status) to 100 (best health status).
Trial Locations
- Locations (40)
University of Iowa
🇺🇸Iowa City, Iowa, United States
Promedica
🇺🇸Toledo, Ohio, United States
Advocate Good Samaritan Hospital
🇺🇸Downers Grove, Illinois, United States
Weill Cornell Medicine
🇺🇸New York, New York, United States
NYU Langone Health - Tisch Hospital
🇺🇸New York, New York, United States
Washington University in St. Louis
🇺🇸Saint Louis, Missouri, United States
University of New Mexico Health Sciences Center
🇺🇸Albuquerque, New Mexico, United States
Christiana Care
🇺🇸Newark, Delaware, United States
Lifespan
🇺🇸Providence, Rhode Island, United States
Loyola University Chicago
🇺🇸Maywood, Illinois, United States
Rutgers New Jersey Medical School
🇺🇸Newark, New Jersey, United States
The Lundquist Institute
🇺🇸Torrance, California, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
MaineHealth
🇺🇸Portland, Maine, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Stanford Medicine
🇺🇸Palo Alto, California, United States
MedStar Health Research Institute
🇺🇸Washington, District of Columbia, United States
Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
Southern Illinois University School of Medicine
🇺🇸Springfield, Illinois, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Trinity Health - Ann Arbor Hospital
🇺🇸Ypsilanti, Michigan, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Main Line Healh
🇺🇸Wynnewood, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
Scripps Memorial Hospital, La Jolla
🇺🇸San Diego, California, United States
Baptist Health Miami Cardiac & Vascular Institute
🇺🇸Miami, Florida, United States
University of Utah Health
🇺🇸Salt Lake City, Utah, United States
Carilion Clinic
🇺🇸Roanoke, Virginia, United States
The University of Alabama At Birmingham
🇺🇸Birmingham, Alabama, United States
UC Davis Health
🇺🇸Sacramento, California, United States
University of South Florida/ Tampa General Hospital
🇺🇸Tampa, Florida, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Sentara Health Research Center
🇺🇸Norfolk, Virginia, United States
Intermountain Health
🇺🇸Murray, Utah, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States