Endologix today announced that the first patient has been enrolled in the company’s JAGUAR study to compare outcomes for the company’s Alto abdominal stent graft system to other commercially available endovascular aneurysm repair (EVAR) devices for the treatment of abdominal aortic aneurysms (AAAs).
JAGUAR (Objective analysis to gauge EVAR outcomes through randomization in a real-world population) is a prospective, randomized, multicenter study that will enroll approximately 450 patients at up to 60 sites worldwide. The study is designed for at least 300 patients to be randomly allocated to the Alto cohort and 150 to the comparator group. All patients will be followed through five years. Results from the study will be independently adjudicated by a third party, Endologix said in a press release.
“The availability of compelling clinical evidence for EVAR devices is crucial for making informed treatment decisions and improving patient outcomes,” said Jean Panneton, MD, vascular surgeon with Sentara Vascular Specialists who treated the patient at Sentara Norfolk General Hospital in Virginia.
The clinical endpoint of the study is a composite of aneurysm-related complications: freedom from device-related interventions, conversion to open surgery, type I and III endoleaks, clinically significant device migration, aneurysm enlargement, occlusion, aneurysm rupture and aneurysm-related death. The study also bears an imaging endpoint related to proximal neck dilation over time, allowing for early insight into mechanisms of graft failure, Endologix said.