Endologix recently announced that it has completed enrolment in the EVAS2 confirmatory clinical study to evaluate the Nellix endovascular aneurysm sealing (EVAS) system.
“The completion of enrolment in our EVAS2 study is an exciting milestone for Endologix and for the treatment of abdominal aortic aneurysms,” commented John Onopchenko, chief executive officer of Endologix. “We are very grateful for the ongoing collaboration and partnership with our investigators who continue to work side-by-side with us to make this trial successful.”
In response to the current COVID-19 pandemic and the delay in recruiting patients across many clinical trials, Endologix submitted an investigational device exemption (IDE) supplement to the US Food and Drug Administration (FDA) with a revised statistical analysis plan that is consistent with the recently published FDA guidance document, “Conduct of clinical trials of medical products during COVID-19 pandemic”.
The submission proposed a minimum sample size of 95 patients, with no alteration to the defined end points of the study. The power of the two-year effectiveness endpoint has been reduced to 87.4% from 93.8%, and the power of the safety endpoint remains 99.9%. The statistical power of both end points remains well above the 80% benchmark typically used in this therapeutic area.
Endologix is currently in the process of preparing a premarket approval (PMA) submission, which it plans to submit shortly after the first 95 patients in the trial reach one-year follow-up in March 2021.