Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy

Launched by NYU LANGONE HEALTH · Oct 18, 2022

Keywords

ClinConnect Summary

The PE-TRACT trial is studying a treatment for pulmonary embolism (PE), which is a serious condition that happens when a blood clot blocks blood flow in the lungs. This trial specifically looks at two approaches: one group of patients will receive catheter-directed therapy (CDT) combined with blood thinners, while another group will only receive blood thinners. The goal is to see which method is more effective for patients with a certain type of PE that involves dilation of the right side of the heart.

To take part in this trial, patients need to be between 65 and 74 years old and have been diagnosed with PE, confirmed by a special scan that shows the clot and the heart's condition. They should also have some symptoms related to PE and show signs of strain on the right side of their heart, which is measured during the scan. Participants will be monitored throughout the trial, and their experiences will help doctors understand the best ways to treat this serious condition. If you or someone you know is considering joining, it’s important to discuss any health concerns with a healthcare provider to see if this trial might be a good fit.

Gender

ALL

Eligibility criteria

• 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