Endologix has begun enrolling patients into its PEVAR clinical trial that will investigate the use of a bilateral percutaneous endovascular abdominal aortic aneurysm repair (PEVAR).
The Irvine, Calif.-based company said that the multicenter, randomized trial will assess the efficacy of its IntuiTrak endovascular delivery system for the Powerlink family of stent graphs on 150 patients at 20 clinical sites.
Rather than standard EVAR procedures that require a surgical opening of the femoral artery, the PEVAR procedure uses a less invasive approach. All patients during the trial will be treated with the IntuiTrak delivery system.
One hundred patients will be treated via PEVAR using pre-close devices--the Prostar XL and the Perclose ProGlide (Abbott)--while the remaining 50 patients will undergo standard EVAR.
According to the company, currently there are no FDA approved devices or clinical trials to assess PEVAR systems.