LEOPARD to Compare Endologix AFX System to Other Commercially Available EVAR Devices

September 29, 2014—Endologix, Inc. announced that it will conduct a prospective, randomized clinical trial to compare outcomes in endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAAs). The company says the LEOPARD trial (Looking at EVAR Outcomes by Primary Analysis of Randomized Data) has been designed to provide an unbiased assessment of commercially available EVAR devices. The planned enrollment is 600 patients.

According to Endologix, LEOPARD will include up to 60 active EVAR centers in the United States. The primary endpoint of the study is treatment success at 1 year based on procedural success as well as rates of freedom from aneurysm rupture, conversion to open surgical repair, endoleaks, clinically significant device migration, aneurysm enlargement, and secondary endovascular procedures. Results from the study will be independently adjudicated by a third-party. The follow-up period will be 5 years.

Christopher J. Kwolek, MD, is the National Principal Investigator for the LEOPARD study. In addition to Dr. Kwolek, the steering committee for the study includes committee Chairman Benjamin Starnes, MD; Daniel Clair, MD; Mark Fillinger, MD; Tom Maldonado; Timothy Sullivan, MD; and Frank Veith, MD.

In the company’s press release, Dr. Kwolek stated, “LEOPARD is a landmark study that is intended to produce the highest level of clinical evidence. I applaud Endologix for supporting a head-to-head real-world comparison of commercially available devices here in the United States. The primary analysis will compare Endologix's AFX endovascular AAA system against an equally matched control population of other commercially available EVAR devices. Results from LEOPARD will help shape EVAR treatment decisions and technology development in order to provide the best possible outcomes for our patients.”

“Endologix is announcing the first ever randomized trial to compare EVAR technologies currently in clinical use," said Endologix's Chief Medical Officer David Deaton, MD, in comments to Endovascular Today. "We’re very excited to sponsor a clinical study that has the potential to generate Level I evidence about EVAR therapy in a ‘real world’ setting. Elevating clinical evidence to a higher level is a primary goal for Endologix. In addition to LEOPARD, we’ve just completed our 300-patient EVAS Forward registry of Nellix therapy well ahead of schedule and are nearing completion of the Nellix IDE study in the United States.”