What is the Purpose of this Study?
The goal of this study is to identify the best way to treat pulmonary embolism (blood clots in the lungs), specifically when there is a large amount of clot, but the patient’s blood pressure is stable. All patients with pulmonary embolism are treated with blood thinner medicines (anticoagulation). Sometimes, doctors will also perform a procedure using a catheter to either remove the clot or give clot-dissolving medicines (catheter-directed therapy). It is not clear whether these procedures help patients who have a large amount of clot but are more stable and at lower risk. This study compares blood thinners alone to blood thinners plus catheter-directed therapy to determine which is more effective.
Both treatment approaches are considered standard care for patients with pulmonary embolism who are stable but who have large amounts of clot. The clot-dissolving medicine and devices used in catheter-directed therapy are approved by the U.S. Food and Drug Administration (FDA) for treatment of pulmonary embolism.
Participants will be randomly assigned to 1 of 2 groups. Group A will be treated with standard blood thinners and will have catheter-directed therapy to deliver a blood clot-dissolving medicine directly into the blood clot and/or suck out the blood clot. Group B will be treated with standard blood thinners alone.
Eligibility
- 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
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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
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Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
PULMONARY EMBOLISM THROMBUS REMOVAL WITH CATHETER-DIRECTED THERAPY: THE PE-TRACT TRIAL