August 6, 2020
First Patient Enrolled in the RESCUE Trial of Thrombolex’s Bashir Catheter to Treat Acute Submassive PE.
Thrombolex Inc. announced that it has enrolled the first patient in its pivotal RESCUE trial for the treatment of patients with acute submassive pulmonary embolism (PE) using the Bashir endovascular catheter under an investigational device exemption (IDE) from the FDA.
RESCUE is a prospective, single-arm, multicenter trial of the Bashir pharmacomechanical device for catheter-directed thrombolysis that will enroll up to 125 patients at up to 20 sites in the United States. The goal of RESCUE is to achieve an additional indication for use of the device in the treatment of PE. The Bashir endovascular catheter received 510(k) premarket regulatory clearance for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
Aravinda Nanjundappa, MD, treated the first patient in the trial at Charleston Area Medical Center, Vascular Center of Excellence, Clinical Trials Center and WVU Vascular Surgery Center at West Virginia University in Charleston, West Virginia. The male patient, age 50 years, had a high-risk submassive pulmonary embolus affecting both lungs.
In the Thrombolex announcement, Dr. Nanjundappa commented, “The patient had an excellent result with no complications following treatment with two Bashir endovascular catheters, 5 hours of infusion, and a total of 14 mg of recombinant tissue plasminogen activator (r-tPA) being administered. We were privileged to enroll the first patient in this important PE trial using the Bashir endovascular catheter.”
According to the company, the RESCUE study follows on the First-in-Human (FIH) trial completed by Thrombolex at the end of 2019. The FIH trial data were presented at the AVF 2020, the annual meeting of the American Venous Forum held March 3-6 in Amelia Island, Florida.
The FIH trial met its primary safety and feasibility endpoints and showed a large and rapid reduction in right heart strain as evidenced by a reduction in right ventricular to the left ventricular ratio of 37% (P < .0009), as well as a 37.1% mean reduction (P < .0005) in pulmonary clot burden, as measured by the Modified Miller Index following infusion of 14 mg of r-tPA over 8 hours. There were no major bleeding or other adverse events.
“Based on the impressive early results of the FIH study, I am excited to see a larger set of real-world data using the Bashir endovascular catheter,” commented RESCUE Steering Committee member Akhilesh Sista, MD, in the Thrombolex press release. Dr. Sista is Section Chief of Vascular & Interventional Radiology at NYU Langone Health in New York, New York.
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