Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy
Purpose
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.
Condition
- Pulmonary Embolism
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
The University of Alabama At Birmingham
Birmingham, Alabama 35233
Birmingham, Alabama 35233
Stanford Medicine
Palo Alto, California 94304
Palo Alto, California 94304
UC Davis Health
Sacramento, California 95817
Sacramento, California 95817
Scripps Memorial Hospital, La Jolla
San Diego, California 92121
San Diego, California 92121
The Lundquist Institute
Torrance, California 90502
Torrance, California 90502
Christiana Care
Newark, Delaware 19718
Newark, Delaware 19718
MedStar Health Research Institute
Washington, District of Columbia 20010
Washington, District of Columbia 20010
Baptist Health Miami Cardiac & Vascular Institute
Miami, Florida 33176
Miami, Florida 33176
University of South Florida/ Tampa General Hospital
Tampa, Florida 33606
Tampa, Florida 33606
Emory University School of Medicine
Atlanta, Georgia 30308
Atlanta, Georgia 30308
University of Chicago Medical Center
Chicago, Illinois 60637
Chicago, Illinois 60637
Advocate Good Samaritan Hospital
Downers Grove, Illinois 60515
Downers Grove, Illinois 60515
Loyola University Chicago
Maywood, Illinois 60153
Maywood, Illinois 60153
Southern Illinois University School of Medicine
Springfield, Illinois 62781
Springfield, Illinois 62781
University of Iowa
Iowa City, Iowa 52242
Iowa City, Iowa 52242
Boston Medical Center
Boston, Massachusetts 02118
Boston, Massachusetts 02118
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
Boston, Massachusetts 02215
University of Michigan
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
Trinity Health - Ann Arbor Hospital
Ypsilanti, Michigan 48197
Ypsilanti, Michigan 48197
Washington University in St. Louis
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
Rutgers New Jersey Medical School
Newark, New Jersey 07103
Newark, New Jersey 07103
University of New Mexico Health Sciences Center
Albuquerque, New Mexico 87131
Albuquerque, New Mexico 87131
NYU Langone Health - Tisch Hospital
New York, New York 10016
New York, New York 10016
Icahn School of Medicine at Mount Sinai
New York, New York 10029
New York, New York 10029
Weill Cornell Medicine
New York, New York 10065
New York, New York 10065
Oregon Health & Science University
Portland, Oregon 97239
Portland, Oregon 97239
University of Pennsylvania
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15232
Pittsburgh, Pennsylvania 15232
Main Line Healh
Wynnewood, Pennsylvania 19096
Wynnewood, Pennsylvania 19096
Medical University of South Carolina
Charleston, South Carolina 29425
Charleston, South Carolina 29425
The University of Texas Health Science Center at Houston
Houston, Texas 77030
Houston, Texas 77030
University of Utah Health
Salt Lake City, Utah 84108
Salt Lake City, Utah 84108
Sentara Health Research Center
Norfolk, Virginia 23507
Norfolk, Virginia 23507
Carilion Clinic
Roanoke, Virginia 24014
Roanoke, Virginia 24014
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
More Details
- NCT ID
- NCT05591118
- Status
- Recruiting
- Sponsor
- NYU Langone Health