Thrombolex Bashir Catheter for Acute PE Studied in Interim Analysis of RAPID-PE

October 28, 2025—Thrombolex, Inc. announced findings from a prespecified interim analysis from the first 50 patients in the postmarket RAPID-PE study.

The prospective, multicenter, single-arm United States RAPID-PE study is evaluating the safety and efficacy of on-the-table (OTT) pharmacomechanical lysis (PML) without postprocedure infusion using the company’s Bashir endovascular catheter (BEC) for the treatment of intermediate-risk acute pulmonary embolism (PE), stated Thrombolex.

Wissam Jaber, MD, Conational Principal Investigator of RAPID-PE, presented the findings during an Innovation Session at the TCT 2025 scientific symposium.

According to the company, the protocol delivers 4 mg of recombinant tissue plasminogen activator into each pulmonary artery (8 mg total for bilateral PE) by multiple hand-injected pulse sprays using an expanded 8-F BEC device.

The prespecified interim analysis includes outcomes for the first 50 patients in the study. To date, 62 of the planned 500 patients have been enrolled; 90% of enrolled patients had high intermediate-risk PE. Commencement of enrollment was announced in October 2024.

As summarized in the Thrombolex press release, the interim results included the following:

• At 7 days, no patients had death or hemodynamic decompensation (the study’s primary endpoint).
• Major bleeding was seen in 2% of patients—one event of access site bleeding 48 hours postprocedure after a loading dose of oral anticoagulant.
• Median total procedure time was 43.5 minutes with a median catheter dwell time of 17.5 minutes.
• Only 8% of patients went to the intensive care unit (ICU) after the procedure.
• Median length of hospital stay was 2.9 days.
• The procedures were performed by 17 operators across various sites.

“This interim cohort demonstrates that OTT, low-dose PML with the BEC device can democratize the catheter-based treatment of intermediate-risk PE patients with excellent safety and remarkably efficient lab times, often without the need for an ICU stay,” commented Dr. Jaber in the Thrombolex press release.