Medtronic have started patient enrolment in the ENGAGE PAS, a post-approval study evaluating the long-term safety and effectiveness of the Endurant stent graft system. Endurant is used to treat abdominal aortic aneurysms (AAA).
The first patient was enrolled at the beginning of August at Parkwest Medical Center in Knoxville, USA, by Christopher Pollock, site’s principal investigator.
“The ENGAGE clinical programme exemplifies Medtronic’s commitment to characterise the real-world, long-term performance of the Endurant stent graft,” said Marc Schermerhorn, leading investigator and chief of Vascular and Endovascular surgery at Beth Israel Deaconess Medical Center and associate professor of surgery at Harvard Medical School, Boston, USA.
“The resulting data will help clinicians worldwide improve their minimally invasive treatment of patients with abdominal aortic aneurysms.”
ENGAGE PAS is a prospective, multicentre, single-arm study designed to demonstrate the long-term safety and effectiveness of the Endurant stent graft in a post-market environment. The study will enrol approximately 325 patients at 25 US centres. Freedom from aneurysm-related mortality at five years after implantation of the stent graft is the primary endpoint of the trial.
The study augments Medtronic’s international ENGAGE Registry, the largest real-world collection of clinical data on a single stent graft ever compiled. Completed in April 2011, the registry enrolled 1,266 patients over two years at 79 sites across 29 countries.
In total, more than 1,800 patients treated with the Endurant will be followed out to five years as part of Medtronic’s global clinical programme for the device.
The FDA approved Endurant in December 2010 for the endovascular treatment of infrarenal abdominal aortic and aorto-iliac aneurysms in patients with specific anatomical characteristics, including adequate femoral or iliac artery access, proximal neck length of at least 10 mm, infrarenal neck angulation of no greater than 60 degrees, and aortic neck diameter of 19 mm to 32 mm.