ENCHANT Will Evaluate ChEVAR Technique With Medtronic's Endurant II/IIs Stent Graft System
January 24, 2018—Medtronic announced the launch of the ENCHANT trial, which will evaluate the chimney endovascular aneurysm repair (ChEVAR) parallel graft technique using the company's Endurant II/IIs stent graft system.
According to Medtronic, ENCHANT will 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. A ChEVAR procedure is a parallel graft chimney technique that uses covered renal stents with a standard aortic stent graft.
The postmarket, noninterventional, multicenter, nonrandomized, single-arm ENCHANT study will enroll approximately 150 patients at 25 sites in Europe and Russia. The study's primary safety endpoint is major adverse events through 30 days after the 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.
ENCHANT's Principal Investigator, Professor Giovanni B. Torsello, MD, and colleagues enrolled the first patient at St. Franziskus Hospital in Münster, Germany.
In the company's announcement, Prof. Torsello commented, "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 standardized approach for treating short infrarenal necks. 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 Endurant II/IIs stent system received CE Mark approval 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 was 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 reinterventions, advised Medtronic.