PE-TRACT Trial of Catheter-Directed Therapy for Pulmonary Embolism Begins Enrollment

July 18, 2023—Akhilesh Sista, MD, who is Principal Investigator of the PE-TRACT randomized controlled trial (RCT), announced that the trial’s first patient has been enrolled by Bedros Taslakian, MD, and his team at NYU Langone Health in New York, New York. Dr. Sista is a professor in the Department of Radiology at Weill Cornell Medicine in New York, New York.

PE-TRACT—Pulmonary Embolism (PE) – Thrombus Removal With Catheter-Directed Therapy—is an independent, investigator-initiated phase 3 clinical trial funded by the National Institutes of Health that seeks to address whether catheter-directed thrombolysis (CDT) improves cardiopulmonary health in patients with submassive PE in the year after the acute PE.

In a February 2023 article in Endovascular Today, “PE-TRACT: A Closer Look,” Dr. Sista provided an overview of the PE-TRACT trial including its place in the PE trial landscape, insight into trial design, potential challenges, and why the trial is a necessity for the future of PE care.

As outlined by Dr. Sista in the article, the trial’s target enrollment is 500 patients, with inclusion criteria of age ≥ 18 years, symptomatic PE diagnosed by contrast-enhanced CT angiography with involvement of a main or lobar pulmonary artery branch, and right ventricular dilation defined by right ventricular/left ventricular ratio > 1.0 on CT angiography.

In the parallel-group, open-label RCT, patients will be randomized 1:1 to receive either CDT or no therapy (ie, anticoagulants alone) with assessments at 1, 3, and 12 months. The completion date for the PE-TRACT trial is estimated as January 2028.

Commenting to Endovascular Today on the initiation of trial enrollment, Dr. Sista stated, “This is a momentous day for the PE community and PE patients. Nearly 10 years after PE-TRACT was conceptualized, the first patient has been enrolled. While we have a long way to go to complete enrollment, we strongly believe that our clinical-site network, with support from our community partners, will pull through and generate the data we have needed so badly for so long.”