Irish medical devices maker Medtronic has stared ENCHANT (Endurant Chevar new indication trial) study.
The post-market, non-interventional, multi-center, non-randomized, single-arm study will enroll approximately 150 patients across 25 sites in Europe and Russia, and will evaluate the safety and performance of a ChEVAR procedure using the Endurant(TM) II/IIs stent graft system in a real-world setting.
The first enrollment at St. Franziskus Hospital in Munster, Germany, was led by Professor Giovanni B. Torsello, M.D., chief of Vascular Surgery and principal investigator for the ENCHANT study.
A ChEVAR procedure refers to the use of a parallel graft chimney technique that uses covered renal stents with a standard aortic stent graft. The study is the first to assess the clinical outcomes, safety, and performance of the ChEVAR technique for treating patients with complex aneurysms with short infrarenal neck lengths of >=2 mm in a real-world setting.
The ENCHANT study's primary safety endpoint is major adverse events through 30 days post-index procedure. The primary performance endpoint is the proportion of enrolled patients who have technical success at the time of the index procedure and are free from secondary interventions through 365 days.
Medtronic aortic and peripheral vascular division’s aortic business general manager and vice president Daveen Chopra said: "As the only stent graft company with a ChEVAR indication, we are deeply invested in delivering solutions, in partnership with the clinical community, that are backed by clinical rigor and address the unmet needs of AAA patients.”
The Endurant II/IIs stent system received CE (Conformité Européenne) Mark for a ChEVAR indication in December 2016.
The approval was supported by the PROTAGORAS study, which demonstrated that standardized use of the Endurant II/IIs stent graft system with ChEVAR in 128 patients is associated with 100 percent technical success, statistically significant aneurysm sac regression (p = .001), 95.7 percent primary patency of the chimney grafts and a low incidence of chimney related reinterventions.
The Endurant II/IIs stent graft system is based on Medtronic's leading Endurant stent graft system, which for the last five years, has been selected for nearly one of every two endovascular AAA repairs globally and has resulted in more than 300,000 successful implants.
The original Endurant system received the CE Mark in June 2008. In the U.S., Food and Drug Administration approval for the Endurant stent graft system was granted in December 2010. In the U.S., the Endurant II/IIs stent system is approved for neck lengths >=10 mm and <=60° infra-renal angulation.