December 12, 2016
TAILOR Postmarket Study Begins for Jotec's E-liac Stent Graft System
December 13, 2016—Jotec GmbH announced that the first patients have been enrolled in the TAILOR prospective, multicenter, postmarket study of the company's branched E-liac stent graft system for the endovascular treatment of iliac aneurysms.
The TAILOR trial's coordinating investigators are Adrien Kaladji, MD, with the CHU Pontchaillou in Nice, France, and Prof. Yann Gouëffic, MD, with the CHU Nantes in Nantes, France.
According to the company, the TAILOR study will evaluate clinical and technical success, as well as the safety and feasibility of the E-liac device to treat unilateral or bilateral aortoiliac or isolated common iliac aneurysms. The main target of the study is the exclusion of aneurysms, with primary patency of the internal iliac artery and external iliac artery on the iliac implantation side.
The cohort study will be composed of 70 male and female patients treated with the E-liac stent graft at 20 European clinical centers that specialize in the endovascular treatment of iliac aortic aneurysms. Data will be collected up to 36 months after intervention.
The Jotec E-liac stent graft system received European CE Mark approval in 2014. The device is the company's latest generation of a side branch device that features an asymmetric spring configuration to achieve high three-dimensional flexibility while maintaining appropriate longitudinal stiffness, according to Jotec.