Nectero Medical today announced initiation of a Phase II/III clinical trial (stAAAble) to investigate the safety and efficacy of the Nectero Endovascular Aneurysm Stabilisation Treatment (Nectero EAST) system in patients with infrarenal abdominal aortic aneurysms (AAAs), maximum diameter 3.5–5cm.
A press release details that the Nectero EAST system is a single-use endovascular system comprised of a dual-balloon delivery catheter and stabiliser 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.
“If proven safe and efficacious, the Nectero EAST system has the potential to positively impact thousands of patients living with aneurysmal disease,” said Grace Wang, associate professor of surgery in the Division of Vascular and Endovascular Surgery at the Hospital of the University of Pennsylvania (Philadelphia, USA) and stAAAble study co-principal investigator. “We are honoured and excited to be one of the participating sites in this groundbreaking trial.”
The stAAAble trial is a prospective, multicentre clinical trial of 400 patients with small- to medium-sized infrareneal AAAs randomised (1:1) to the Nectero EAST system versus active surveillance, the current standard of care. Patients will be enrolled across multiple sites, predominantly in the USA. The primary endpoint is the composite of all AAA-related death, rupture and repair (open-surgical, endovasular aneurysm repair [EVAR], 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 computed tomography (CT) scan core laboratory readings at 24 months. The study will have continued follow-up annually at three, four and five years.
“The Nectero EAST system aims to be the first proven early intervention therapy for small- to mid-sized AAAs,” commented Jack Springer, president and chief executive officer of Nectero Medical. “Initiation of our randomised clinical trial is a significant milestone in our journey to bring this potentially transformative therapy to AAA patients.”
