Recently, Medtronic announced that it has successfully enrolled its first patient in its head-to-head research comparing two distinct aortic stent graft systems.
During the course of the Advance research, the Medtronic Endurant II/IIs and the Gore Excluder AAA device series will each be evaluated and put through their paces.
In a press statement, Medtronic said that the experiment might include as many as 550 individuals from up to fifty separate locations all over the globe. Patients will be randomly assigned to receive grafts from either the Endurant or Excluder families for endovascular aneurysm repair (EVAR). A month later, a year later, and every year for the next five years, we’ll check in with you.
At the Novant Health Forsyth Medical Center in Winston-Salem, North Carolina, Dr. Ray Workman and his colleagues enrolled the first patient, who was identified as patient number one.
According to comments of the trial’s co-principal investigator and head of vascular surgery at Erasmus MC in Rotterdam, Netherlands, Hence Verhagen, the organisation’s team wants to further establish sac regression as a significant predictor of long-term EVAR patient outcomes via the Advance experiment.
The objective is to ensure that the results will empower clinicians to make treatment choices based on research findings to enhance long-term clinical effects.
With the aid of a separate core laboratory, CT imaging will be examined in order to fully understand sac regression. The study’s findings will demonstrate how effectively each stent transplant reduces the size of aneurysm sacs. Other significant clinical consequences include endoleaks, mortality, migration, future treatments, and renal issues.
Endovascular repair of aneurysms, including aortoiliac or infrarenal abdominal aortic aneurysms, utilising the Endurant stent graft is one of the recognised indications for this device. According to Medtronic, recent research lends credence to the hypothesis that there is a connection between sac regression and sustained efficacy. This theory takes into account subsequent reinterventions as well as mortality rates.
The Advance experiment is based on the clinical data that one-year sac regression gives early signs of higher long-term survival. This evidence is the trial’s cornerstone. The findings, when taken into consideration as a whole, were consistent with Endurant’s outstanding performance in the Engage OUS registration over a span of eight years. That was connected to clinical safety and efficacy over a large amount of time.
The co-principal investigator of the trial and the director of vascular and endovascular surgery at Beth Israel Deaconess Medical Center in Boston, Massachusetts, Dr. Marc Schermerhorn, remarked that the team at the institution is pleased to unveil the first patient registration for the ADVANCE Trial.
Elaborating further, he said that this accomplishment highlights the dedication to a thorough examination of the long-term data pertaining to the endurance of the Endurant system for patients in need of EVAR. The trial’s findings are intended to illustrate current findings and the institute’s main objective of providing improved aortic care delivery via solid and thorough trial information.
