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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
500
All subjects will receive anticoagulation for a minimum of 3 months.
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
Peak Oxygen Consumption (PVO2)
PVO2 measured during cardiopulmonary exercise test (CPET).
Time frame: Month 3
New York Heart Association (NYHA) Functional Classification
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.
Time frame: Month 12
Incidence of Major Bleeding at 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.
Time frame: Up to Day 7
Six-Minute Walk Distance (6MWD)
Time frame: Month 12
Short-Form Health Survey-36 (SF-36) Score
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).
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The University of Alabama At Birmingham
Birmingham, Alabama, United States
RECRUITINGStanford Medicine
Palo Alto, California, United States
RECRUITINGUC Davis Health
Sacramento, California, United States
RECRUITINGScripps Memorial Hospital, La Jolla
San Diego, California, United States
RECRUITINGThe Lundquist Institute
Torrance, California, United States
RECRUITINGChristiana Care
Newark, Delaware, United States
RECRUITINGMedStar Health Research Institute
Washington D.C., District of Columbia, United States
RECRUITINGBaptist Health Miami Cardiac & Vascular Institute
Miami, Florida, United States
RECRUITINGUniversity of South Florida/ Tampa General Hospital
Tampa, Florida, United States
RECRUITINGEmory University School of Medicine
Atlanta, Georgia, United States
RECRUITING...and 30 more locations
Time frame: Month 12
Incidence of Clinical Deterioration (Fatal and Non-Fatal) at Day 7
Clinical deterioration defined as hemodynamic decompensation or respiratory decompensation requiring endotracheal intubation.
Time frame: Up to Day 7