Medtronic has announced the launch of the ENCHANT (Endurant ChEVAR New Indication Trial) study. The post-market, non-interventional, multi-centre, non-randomised, single-arm study will enrol approximately 150 patients across 25 sites in Europe and Russia, and will evaluate the safety and performance of a ChEVAR procedure using the Endurant II/IIs stent graft system in a real-world setting. The first enrolment at St Franziskus Hospital in Munster, Germany, was led by Giovanni B Torsello, 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 ≥2mm in a real-world setting.
“We are excited to initiate this study in a real-world population, which will build upon existing clinical evidence for the ChEVAR technique as a standardised approach for treating short infrarenal necks,” Torsello says. “We believe the ENCHANT study marks another significant milestone for patients with complex forms of aortic disease who, until recently, had not been suitable for a minimally-invasive endovascular procedure.”
The primary safety endpoint of the ENCHANT study 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.
“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 rigour and address the unmet needs of AAA patients,” said Daveen Chopra, vice president and general manager of the Aortic business, part of the Aortic & Peripheral Vascular division at Medtronic. Chopra added, “This is the first industry-sponsored study to evaluate the ChEVAR technique in this patient population”.
The Endurant II/IIs stent system received CE mark for a ChEVAR indication in December 2016. The approval was supported by the PROTAGORAS study, which demonstrated that standardised use of the Endurant II/IIs stent graft system with ChEVAR in 128 patients is associated with 100% technical success, statistically significant aneurysm sac regression (p=.001), 95.7% primary patency of the chimney grafts and a low incidence of chimney related re-interventions.
For the last five years, the Endurant stent graft system 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. US FDA approval for the Endurant stent graft system was granted in December 2010. In the USA, the Endurant II/IIs stent system is approved for neck lengths ≥10mm and ≤60° infra-renal angulation.