NIH - Sponsored Trial of Pharmaco-mechanical Thrombolysis with the BASHIRTM Endovascular Catheter Demonstrates Unprecedented Reduction in Pulmonary Artery Obstruction in Patients with Acute Pulmonary Embolism
Thrombolex, Inc. today presented the final results of its NIH -sponsored RESCUE trial during the Late Breaking Innovation Session at TCT2022 in Boston. This investigational device exemption (IDE) trial demonstrated that pharmaco-mechanical catheter-directed thrombolysis (PMCDT) therapy using the Bashir Endovascular Catheter from Thrombolex led to a significant improvement in right ventricular function with an excellent safety profile. The magnitude of reduction in PA obstruction in the RESCUE trial was markedly greater than what has been reported in other contemporary pulmonary embolism (PE) trials.
The RESCUE trial is a prospective, multicenter trial evaluating the Bashir Catheter in 109 patients with intermediate risk acute PE at 18 sites in the United States. The Bashir Catheter was used to deliver 7mg of recombinant tissue plasminogen activator (r-tPA) into each pulmonary artery (PA) over a 5-hour infusion period. The primary efficacy endpoint was the core lab-assessed change in the CTA-derived mean RV/LV (right ventricular to left ventricular) diameter ratio at 48 hours, and the primary safety endpoint was serious adverse events, including major bleeding at 72 hours.
The median device placement time was 15 minutes and length of hospital stay was 2.8 days. At 48 hours after delivering r-tPA, the RV/LV ratio decreased from baseline by 0.56, a reduction of 33.3% (p<0.0001). A key secondary efficacy endpoint was the core lab assessed reduction in PA obstruction as measured by the refined Modified Miller Index (MMI), which demonstrated a reduction of 35.9% (p<0.0001). Compared to other contemporary core lab-assessed CDT trials, this reduction in PA obstruction was more than two-fold greater with the Bashir Catheter, per mg of r-tPA administered.
"The RESCUE trial demonstrated extremely rapid resolution of thrombus and a remarkable reduction in PA obstruction, with a less than a 1% rate of major bleeding. This represents a major advance in the treatment of acute PE," said Dr. Kenneth Rosenfield, co-Principal Investigator of the RESCUE study and Section Head, Vascular Medicine & Intervention at the Massachusetts General Hospital.
“We are absolutely delighted with the results of the RESCUE trial and thank all those who made this possible, especially our physician investigators and their patients. We would also like to thank the NIH and the Commonwealth of Pennsylvania Department of Health for their support,” said Marvin Woodall, Executive Chairman of Thrombolex.
Founded in 2016, Thrombolex is engaged in the design, development and distribution of innovative endovascular catheters used in interventional procedures, particularly in pharmaco-mechanical catheter-directed thrombolysis (PMCDT) in patients who suffer from arterial and venous thromboembolic (VTE) conditions. The Company is currently marketing seven (7) different FDA cleared devices that are all based on the BASHIRTM Endovascular Catheter platform technology.