RecruitingPhase 3

Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy

United States500 participantsStarted 2023-07-17

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion 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

Exclusion criteria

✕. Age \< 18 years
✕. 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.
✕. 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))

What they're measuring

Peak Oxygen Consumption (PVO2)

Timeframe: Month 3

New York Heart Association (NYHA) Functional Classification

Timeframe: Month 12

Incidence of Major Bleeding at Day 7

Timeframe: Up to Day 7

Trial details

NCT IDNCT05591118

SponsorNYU Langone Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03-29

Contact for this trial

Sunil Rao

212-263-0456 Sunil.rao@nyulangone.org

View on ClinicalTrials.gov More Pulmonary Embolism trials