Nectero Medical Begins stAAAble Trial of the Nectero EAST System

January 18, 2024—Nectero Medical announced initiation of stAAAble, the phase 2/3 clinical trial investigating the safety and efficacy of the Nectero endovascular aneurysm stabilization treatment (EAST) system in patients with infrarenal abdominal aortic aneurysms (AAAs) with maximum diameters of 3.5 to 5 cm.

In July 2023, Nectero Medical announced that the FDA granted an investigational new drug clearance for the company to initiate the trial.

According to the company, the prospective, multicenter stAAAble clinical trial will be composed of 400 patients with small- to medium-sized infrareneal AAAs. The patients will be enrolled across multiple sites, predominantly in the United States.

Patients in the trial will be randomized (1:1) to the Nectero EAST system or to active surveillance, the current standard of care.

The company noted that the trials primary endpoint is the composite of all AAA-related death, rupture and repair (open surgical, endovascular aneurysm repair, or clinically indicated for repair as adjudicated by a committee of clinical experts blinded to the assigned arm). The secondary endpoint is growth in aneurysm diameter over time based on CT scan core laboratory readings at 24 months. The study will have continued follow-up annually at 3, 4, and 5 years.

The Nectero EAST system is a single-use, endovascular system comprised of a dual-balloon delivery catheter and stabilizer mixture containing pentagalloyl glucose (PGG). The system delivers PGG locally into the aneurysmal wall, where it can bind to elastin and collagen to potentially strengthen the aortic vessel wall and reduce the risk of further degradation, stated the company.

Nectero Medical noted that early phase I clinical results from the first-in-human study were recently published online by Stephen W.K. Cheng, MS, et al in the Journal of Vascular Surgery (2023;78:929-935).

“If proven safe and efficacious, the Nectero EAST system has the potential to positively impact thousands of patients living with aneurysmal disease,” commented study Coprincipal Investigator Grace Wang, MD, in the company’s press release. “We are honored and excited to be one of the participating sites in this groundbreaking trial.” Dr. Wang is Associate Professor of Surgery in the Division of Vascular and Endovascular Surgery at the Hospital of the University of Pennsylvania in Philadelphia, Pennsylvania.