First Enrolment For Medtronic’s ADVANCE Trial
Medical device company Medtronic recently announced the first enrolment of a patient in the ADVANCE trial, which is a head to head randomized controlled trial between two aortic stent graft systems. The Medtronic Endurant II/IIs stent graft system is the first, against the Gore Excluder AAA device family stent graft systems. This ADVANCE trial is a global, interventional, prospective, multicentre randomized study which will enrol 550 patients minimum at up at 50 centres around the world. Patients are randomized to receive EVAR (endovascular aneurysm repair) using either the Endurant or Excluder family grafts, which will then be followed at a month, a year, and then annually through the next five years.
The first patient to be enrolled in the trial was at Novant Health Forsyth Medical Center, in the USA. “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, professor of Vascular Surgery at Erasmus Medical Center (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.” The aim of the ADVANCE trial is to further the understanding of sac regression using robust evaluation of CT imaging which utilises an independent core lab over a five year period, providing an aneurysm sac regression outcome comparison between the two stent graft systems. Additional evidence will also be provided to analyse aneurysm-related risk factors for those which fail to regress.
The trial also aims to compare certain other key clinical outcomes, which include migration, endoleaks, mortality, secondary intervention and renal complications. “We are pleased to announce the first patient enrolled in the ADVANCE trial,” said Marc Schermerhorn, chief of vascular and endovascular surgery, Beth Israel Deaconess Medical Center (Boston, USA) 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.” The ADVANCE trial draws off clinical data which demonstrates that one year sac regression acts as an early indicator of improved long term survival.
© Medtronic Plc