BridgeMD
New treatment option for Pulmonary Embolism
Official title Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy
ClinicalTrials.gov ID: NCT05591118
What this study is testing
What is Anticoagulant Therapy?
Anticoagulant Therapy is an investigational medicine, being studied as a potential treatment for pulmonary embolism.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Age \< 18 years
- Systolic blood pressure \ 15 consecutive minutes or \> 40 mmHg drop from baseline, or vasopressor requirement for blood pressure support (i.e...
- Symptom duration \> 14 days for the current PE episode
- Irreversible INR \> 3
- Irreversible Thrombocytopenia (Platelets \< 50,000/microliter)
- Creatinine \> 2.0 mg/dl
See the full eligibility criteria
- 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 \ 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
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Palo Alto, California, United States
- Sacramento, California, United States
- San Diego, California, United States
- Torrance, California, United States
- Newark, Delaware, United States
- Washington D.C., District of Columbia, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Downers Grove, Illinois, United States
- Maywood, Illinois, United States
- Springfield, Illinois, United States
- Iowa City, Iowa, United States
- Portland, Maine, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Ypsilanti, Michigan, United States
- St Louis, Missouri, United States
+ 16 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Palo Alto, California, United States; Sacramento, California, United States; San Diego, California, United States; Torrance, California, United States; Newark, Delaware, United States and 30 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.