Sam Brusco, Associate Editor01.12.23
Medtronic announced the first patient enrollment in the ADVANCE trial, a head-to-head trial of two leading aortic stent graft systems, the Medtronic Endurant II/IIs and GORE Excluder AAA device family systems.
It will enroll a minimum of 550 patients at up to 50 centers globally. Patients will be randomized to receive endovascular aneurysm repair (EVAR) with either the Endurant or Excluder family grafts. The patients will be followed at one month, one year, and annually through five years.
“Through the ADVANCE Trial, we are working to deepen our evidence of sac regression as a key indicator of long-term EVAR patient outcomes,” Prof. Hence Verhagen, Professor of Vascular Surgery, head of Vascular Surgery Erasmus MC, Rotterdam, Netherlands, and co-principal investigator of the trial, told the press. “Our hope is that the findings will allow physicians to make evidence-based clinical decisions to improve long-term patient outcomes.”
The trial aims to further understanding of sac regression outcomes between the two stent grafts, with additional evidence to analyze risk factors related to aneurysms that fail to regress. The trial will also compare endoleaks, migration, secondary interventions, mortality, and renal complications between the two devices.
“We are pleased to announce the first patient enrolled in the ADVANCE Trial,” said Marc Schermerhorn, MD, Chief of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center in 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.”
The trial draws on data showing one-year sac regression is an early indicator of better long-term survival.1
References
1 O’Donnell TFX, Deery SE, Boitano LT, et al. Aneurysm sac failure to regress after endovascular aneurysm repair is associated with lower long-term survival. J Vasc Surg. February 2019;69(2):414-422.
It will enroll a minimum of 550 patients at up to 50 centers globally. Patients will be randomized to receive endovascular aneurysm repair (EVAR) with either the Endurant or Excluder family grafts. The patients will be followed at one month, one year, and annually through five years.
“Through the ADVANCE Trial, we are working to deepen our evidence of sac regression as a key indicator of long-term EVAR patient outcomes,” Prof. Hence Verhagen, Professor of Vascular Surgery, head of Vascular Surgery Erasmus MC, Rotterdam, Netherlands, and co-principal investigator of the trial, told the press. “Our hope is that the findings will allow physicians to make evidence-based clinical decisions to improve long-term patient outcomes.”
The trial aims to further understanding of sac regression outcomes between the two stent grafts, with additional evidence to analyze risk factors related to aneurysms that fail to regress. The trial will also compare endoleaks, migration, secondary interventions, mortality, and renal complications between the two devices.
“We are pleased to announce the first patient enrolled in the ADVANCE Trial,” said Marc Schermerhorn, MD, Chief of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center in 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.”
The trial draws on data showing one-year sac regression is an early indicator of better long-term survival.1
References
1 O’Donnell TFX, Deery SE, Boitano LT, et al. Aneurysm sac failure to regress after endovascular aneurysm repair is associated with lower long-term survival. J Vasc Surg. February 2019;69(2):414-422.
