Medtronic (NYSE:MDT) today announced that it enrolled the first patient in a head-to-head trial of aortic stent graft systems.
The Advance trial evaluates the Medtronic Endurant II/IIs and the Gore Excluder AAA device family.
Medtronic said in a news release that it expects to enroll 550 patients at up to 50 global centers in the trial. After that, the plan is to randomize patients to receive endovascular aneurysm repair (EVAR). The EVAR would come from either the Endurant or Excluder families of grafts. Follow-up comes at one month, one year and annually throughout five years.
Dr. Ray Workman and his team at Novant Health Forsyth Medical Center (Winston-Salem, North Carolina) enrolled the first patient.
“Through the Advance trial, we are working to deepen our evidence of sac regression as a key indicator of long-term EVAR patient outcomes,” said Hence Verhagen, head of vascular surgery, Erasmus MC, Rotterdam, Netherlands, and co-principal investigator of the trial. “Our hope is that the findings will allow physicians to make evidence-based clinical decisions to improve long-term patient outcomes.”
Advance aims to evaluate CT imaging using an independent core lab to further the understanding of sac regression. The trial will provide a comparison of aneurysm sac regression outcomes between the two stent grafts. Other key clinical outcomes include endoleaks, migration, secondary interventions, mortality and renal complications.
More about the Medtronic Endurant stent graft
The Endurant stent graft holds an indication for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms.
Medtronic said that current research demonstrates that sac regression can result in better long-term outcomes. That includes mortality and secondary reinterventions.
The Advance trial draws on clinical data showing that one-year sac regression offers early indications of improved long-term survival. The outcomes fell in line with eight-year results from the Engage OUS registry that demonstrated positive outcomes with Endurant. That included long-term clinical safety and effectiveness.
“We are pleased to announce the first patient enrolled in the ADVANCE Trial,” said Dr. Marc Schermerhorn, chief of vascular and endovascular surgery, Beth Israel Deaconess Medical Center, Boston, Massachusetts, and co-principal investigator of the trial. “This milestone underscores the commitment to rigorous study of the long-term data around the durability of the Endurant system for patients in need of EVAR. The results of the trial aim to demonstrate contemporary outcomes and our overarching goal to deliver superior aortic patient care through robust and rigorous clinical data.”