Enrollment Continues in Postmarket Registry for Jotec's E-liac System

April 17, 2015—Jotec GmbH announced continuing enrollment in the PLIANT postmarket registry of the company’s new-generation, low-profile E-liac stent graft system in patients with iliac aneurysm undergoing endovascular stent treatment. Jotec announced in January 2014 that the E-liac system received European CE Mark approval for the endovascular treatment of aortoiliac aneurysms or isolated iliac aneurysms.

Patient enrollment started in July 2014, and the first 10 patients have been included in the registry. The study will enroll 40 male and female patients treated with the E-liac stent graft with follow-up to 36 months after intervention. The study is planned to be completed in 2018, advised the company.

The study is being led by Principal Investigator Prof. Jan Brunkwall, MD, from the University Hospital Cologne in Germany. The cohort study is being conducted at 11 or more European clinical centers specializing in the endovascular treatment of iliac aortic aneurysms.  

According to Jotec, the objectives of the multicenter study are to evaluate clinical and technical success as well as safety and feasibility of the E-liac system used in endovascular treatment of unilateral or bilateral aortoiliac or isolated common iliac aneurysms. The main target of the study is the exclusion of aneurysm with primary patency of the internal iliac artery and external iliac artery on the iliac implantation side.