Cook Medical (Cook), is planning to complete clinical trial entitled “Evaluation of the Safety and Effectiveness of the Zenith Low Profile AAA Endovascular Graft” for Zenith Low Profile Abdominal Aortic Aneurysm (AAA) Endovascular Graft by May 2015. The aim of the study is to find the safety and effectiveness of the Zenith Low Profile AAA Endovascular Graft in the treatment of abdominal aortic, aorto-iliac, and iliac aneurysms.
The open label, single group assignment trial is currently recruiting approximately 120 participants.
Zenith Low Profile Abdominal Aortic Aneurysm Endovascular Graft is intended for the endovascular repair of aortic disease. It provides smaller endograft delivery system that will permit treatment of AAA patients with smaller vascular anatomies. It employs a 16 French delivery sheath, significantly thinner in diameter. It enables physicians to reduce the need for a surgical cut down to access the femoral artery for device insertion, thereby allowing the use of the less-invasive percutaneous entry technique.