Physician-Initiated ASCEND Registry to Evaluate the Endologix Nellix EVAS System

November 18, 2015—Endologix, Inc. announced the start of a physician-initiated registry of the Nellix endovascular aneurysm sealing (EVAS) system used with aortic branch stent grafts for the treatment of patients with complex abdominal aortic aneurysms (AAAs). The registry, which will be called ASCEND (Aneurysm Study for Complex AAA: Evaluation of Nellix Durability), will be conducted outside of the United States.

According to Endologix, the ASCEND registry will enroll 200 patients with complex AAAs at up to 10 international centers. The complex anatomies include juxtarenal and pararenal AAAs. It will be an open-label, single-arm, observational, real-world registry with no prospective screening. The endpoints of the ASCEND registry include overall and aneurysm-related mortality, major adverse events, endoleak and secondary intervention rates, Nellix and aortic branch stent graft patency, renal function, and durability.

The Primary Investigators are Andrew Holden, MD, and Matthew Thompson, MD. Dr. Holden is Associate Professor of Radiology at Auckland Hospital in Auckland, New Zealand. Prof. Thompson is Professor of Vascular Surgery at St. Georges Vascular Institute in London, United Kingdom.

In the company’s press release, Prof. Thompson commented, “Given our positive initial experience utilizing Nellix with aortic branch stent grafts for the treatment of complex AAAs, we look forward to initiating the ASCEND registry to evaluate the use of EVAS to treat this patient population.”

Prof. Thompson further noted, “Complex AAAs represent more than one-third of patients with abdominal aneurysms, and the management of these patients remains difficult. Treatment options include open surgical treatment, which has a high rate of mortality and morbidity, and custom-made endovascular devices, which are technically challenging and only address a limited proportion of patients with complex aneurysms. Similar to utilizing Nellix for infrarenal AAA cases, Nellix with aortic branch stent grafts has the potential to address a wide range of patients with complex aortic morphologies that are unsuitable for both EVAR and open surgical repair.”

The Nellix EVAS system, which was developed to mitigate all types of endoleaks, and improve stability and long-term patient outcomes, is designed to seal the entire aneurysm sac. The device received European CE Mark approval in 2013 for the treatment of patients with infrarenal AAAs. It is an investigational device in the United States.