JAGUAR RCT of Endologix Alto EVAR Device Marks Enrollment Milestone

May 23, 2023—Endologix LLC, announced an enrollment milestone in the JAGUAR randomized controlled trial evaluating the effectiveness of the company’s Alto abdominal stent graft system compared to other commercially available endovascular aneurysm repair (EVAR) devices in the treatment of abdominal aortic aneurysms. The company advised that 150 of a planned 450 patients have been enrolled in the study, which commenced in September 2021.

According to the company, the prospective, multicenter JAGUAR study is designed to enroll 450 patients at up to 60 sites, with 300 patients randomly assigned to the Alto cohort and 150 allocated to the comparator devices group. The study will follow patients through 5 years, with outcomes independently adjudicated.

The company advised that JAGUAR has two primary endpoints:

• The clinical endpoint is a composite of aneurysm-related complications, which include 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 imaging endpoint is related to proximal neck dilation over time and allows for early insight into mechanisms of graft failure.

According to Endologix, Alto utilizes a low-profile delivery system and features the company’s adaptive sealing technology that molds in situ to the patient’s specific aortic neck anatomy. In July 2020, the company announced the United States launch of the Alto device after receiving FDA approval in March 2020. The company subsequently received CE Mark approval and introduced the device in Europe and other international markets.

Alto is the company’s latest-generation abdominal stent graft system, joining the Endologix AFX endograft system in the company’s EVAR portfolio. In April 2023, the company announced the publication of final 5-year results of the LEOPARD randomized controlled trial comparing outcomes of EVAR using the Endologix AFX endograft system with anatomical fixation versus commercially available endografts with proximal fixation in a real-world population.