Thrombolex RESCUE II Study Begins Patient Enrollment

January 22, 2024—Thrombolex, Inc. announced the enrollment of the first patient in the RESCUE II study using the company’s Bashir endovascular catheter for the treatment of acute intermediate-risk pulmonary embolism (PE).

The initial procedure was performed by Riyaz Bashir, MD, and Vladimir Lakhter, DO, at Temple University Hospital in Philadelphia, Pennsylvania.

According to Thrombolex, the RESCUE II study is evaluating the efficacy of on-table pharmacomechanical lysis (PML) without postprocedural thrombolytic infusion using the new 0.035-inch, guidewire-compatible Bashir endovascular catheter.

In the trial, patients with acute intermediate-risk PE will be treated with four 1-mg pulse sprays of recombinant tissue plasminogen activator (rtPA) into each lung without subsequent rtPA infusion, which generally requires admission to an intensive care unit (ICU).

Parth Rali, MD, is Principal Investigator of RESCUE II and Associate Professor of Thoracic Medicine and Surgery at Lewis Katz School of Medicine at Temple University.

“It was exciting to see a dramatic on-table hemodynamic improvement in a patient with a low cardiac index using the RESCUE II protocol,” commented Dr. Rali in the company’s press release. “This approach may eliminate the need for an ICU stay, which would be a boon to the overburdened health systems and open the technology to a much wider array of hospitals, including those that do not have ICUs.”

Dr. Bashir added, “We are pleased to enroll the first patient in the RESCUE II study and are very encouraged by the clinical and hemodynamic response with this novel PML approach. This logical next step in advancing this therapy could be another significant milestone following the recently published RESCUE trial.” Dr. Bashir is Professor of Medicine at the Lewis Katz School of Medicine.

The RESCUE trial, which enrolled 109 patients with intermediate-risk PE at 18 hospitals in the United States, demonstrated efficacy and safety in this patient population, advised Thrombolex.

In October 2023, the company announced that an independent core lab data analysis from the RESCUE trial was published by Dr. Bashir et al online in JACC: Advances.