Nectero Medical Launches Phase II/III Trial for Nectero EAST® in Abdominal Aortic Aneurysms

Nectero Medical, a biotech firm specializing in innovative aneurysmal disease treatments, has launched a Phase II/III clinical trial named stAAAble. The trial is designed to assess the safety and efficacy of the Nectero EAST® System, an endovascular treatment for infrarenal abdominal aortic aneurysms (AAAs) with a maximum diameter of 3.5 to 5.0cm. The system, which is a single-use device, includes a dual-balloon catheter and a stabilizer mixture with pentagalloyl glucose (PGG). The PGG is intended to bind to elastin and collagen in the aneurysm wall, potentially fortifying the aortic wall and mitigating the risk of further deterioration.
Dr. Grace Wang, a vascular surgery expert and co-principal investigator of the stAAAble study, expressed enthusiasm for the potential positive impact on patients with aneurysmal disease. The trial will enroll 400 subjects across multiple U.S. sites, with a 1:1 randomization to the Nectero EAST System or active surveillance, which is the current standard of care. The primary outcome measure will be a composite of AAA-related mortality, rupture, and repair, while the secondary endpoint will focus on aneurysm diameter growth over 24 months, as determined by CT scan readings. Follow-up assessments are scheduled annually for three to five years post-trial.
Jack Springer, CEO of Nectero Medical, highlighted the system's potential as an early intervention for small to mid-sized AAAs. The Nectero EAST System is intended for infrarenal AAA treatment and could offer a new therapeutic option for the over 1 million diagnosed Americans living with the condition. Current treatments are typically reserved for larger aneurysms or those with specific risk factors, while smaller ones are monitored with imaging. The procedure is designed to be straightforward for vascular surgeons familiar with endovascular techniques, quick to perform, and does not leave a permanent implant or preclude future interventions. Preliminary clinical results have been published in the Journal of Vascular Surgery, and the stAAAble trial aims to further evaluate the system's effectiveness in treating AAAs of the specified size range. If successful, the Nectero EAST System could provide an alternative to surveillance for patients with smaller aneurysms.