Endologix has 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.
The Registry, to be conducted outside of the USA, will be called the ASCEND Registry (Aneurysm study for complex abdominal aortic aneurysms: Evaluation of Nellix durability). The primary investigators are Andrew Holden, associate professor of Radiology at Auckland Hospital, Auckland, New Zealand, and Matthew Thompson, professor of Vascular Surgery, St Georges Vascular Institute, London, UK. The Nellix system received CE mark in 2013 for the treatment of patients with infrarenal abdominal aortic aneurysms. Nellix is an investigational device in the USA.
Thompson said, “Given our positive initial experience utilising Nellix with aortic branch stent grafts for the treatment of complex abdominal aortic aneurysms, we look forward to initiating the ASCEND Registry to evaluate the use of EVAS to treat this patient population. Complex aneurysms 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 utilising Nellix for infrarenal abdominal aneurysm 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 ASCEND Registry will enrol 200 patients with complex abdominal aortic aneurysms at up to 10 international centres. The complex anatomies include juxta-renal and para-renal aneurysms. 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 Nellix EVAS system is a new generation of aneurysm therapy designed to seal the entire aneurysm sac. Nellix says that it is the first and only EVAS product and was developed to mitigate all types of endoleaks, improve stability and long-term patient outcomes.