RAPID-PE is a single-arm, prospective, multicenter trial designed to assess the safety and efficacy of OTT PML without post-procedure infusion. The protocol delivers 4 mg r-tPA into each pulmonary artery (8 mg total for bilateral PE) by multiple hand-injected pulse sprays using an expanded 8 Fr BEC device. The dual mechanism of action of the BEC device creates immediate mechanical fissures to restore blood flow while enabling low-dose lytic to act within and beyond the clot. The prespecified interim analysis reports outcomes for the first 50 patients (62 of the 500 patients have been enrolled to date).
This study enrolled mostly (90%) high intermediate-risk PE patients and showed that none of the patients had death or hemodynamic decompensation at 7 days, which is the primary endpoint of the study. Major bleeding (by ISTH criteria) was seen in 2% (1 event; access-site bleed 48 hours post-procedure after a loading dose of oral anticoagulant). The median total procedure time was 43.5 minutes with a median catheter dwell time of 17.5 minutes. Only 8% of patients went to ICU after the procedure and the median length of hospital stay was 2.9 days. These procedures were performed by 17 different operators across various participating sites.
Wissam Jaber, MD (Emory University), the presenting author and RAPID-PE Co-national PI, commented: “This interim cohort demonstrates that On-The-Table, 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.”
Marvin Woodall, Executive Chairman, Thrombolex Inc, added: “RAPID-PE continues to validate our Pharmaco-Mechanical approach, with mechanical blood flow restoration plus targeted low-dose lysis that may reduce ICU utilization and overall resource burden while maintaining strong clinical outcomes. We look forward to completing enrollment and sharing the full results.”
About Thrombolex, Inc.
Founded in 2016, Thrombolex is engaged in the design, development and distribution of innovative endovascular catheters used in interventional procedures, particularly in pharmaco-mechanical lysis (PML) in patients who suffer from arterial and venous thromboembolic (VTE) conditions. The Company is currently marketing eight (8) different FDA cleared devices that are all based on the BASHIR™ Endovascular Catheter platform technology.
For general inquiries, please contact Thrombolex at info@thrombolex.com or for more information about Thrombolex and its solutions, visit www.thrombolex.com
