The post-market, non-interventional, multicentre, non-randomised, 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 II/IIs stent graft system (Medtronic) 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.
ChEVAR 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 greater than or equal to 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,” said Torsello. “We believe the 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 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, a press release from the company states.
“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 abdominal aortic aneurysm patients,” said Daveen Chopra, vice president and general manager of the Aortic business, which is part of the Aortic & Peripheral Vascular division at Medtronic.
The Endurant II/IIs stent system received CE mark for a ChEVAR indication in December 2016.