ADVANCE trial to provide for clinical decision-making

It's estimated that 1.1 million people in the U.S. and more than 2.5 million people worldwide are living with an abdominal aortic aneurysm. While many aneurysms are relatively small and are monitored for growth, others require surgery. A ruptured AAA is life-threatening.  

In the 35 years since the world’s first successful endovascular aneurysm repair (EVAR), mortality and complication rates have declined significantly. By 2010, with the improvement in techniques and technology, just 26 percent of abdominal aortic aneurysm (AAA) repairs were performed as open surgeries. And today, with multiple aortic stent graft systems now available, physicians are searching for hard data to guide decision-making and improve care.  

UK's Gill Heart & Vascular Institute is participating in the ADVANCE trial, a global, randomized controlled study comparing two leading aortic stent graft systems. The worldwide study will follow patients for five years after EVAR with either the Medtronic Endurant II/IIs Stent Graft Systems or the Gore Excluder/Excluder Conformable AAA Endoprosthesis.  

“We will evaluate outcomes like aneurysm sac regression, endoleaks, device migration, secondary interventions, mortality and renal complication,” said site principal investigator and vascular surgeon Dr. Sam Tyagi.

“By analyzing detailed CT imaging and long-term patient data, the trial aims to provide critical evidence to guide clinical decisions and improve outcomes for patients with abdominal aortic aneurysms.” 

Patients eligible for the ADVANCE study include men with an aneurysm diameter greater than 5.5 centimeters and women with an aneurysm diameter greater than 5.0 centimeters. The patient’s anatomy must be appropriate for either system. Certain types of aneurysms, as well as patients with connective tissue disease that may have caused the aneurysm may not participate.  

Follow-up points with patients occur at one month, one year and annually through five years.

Learn more about clinical trials at Gill by clicking here.