Objective: Endovascular repair of abdominal aortic aneurysms (AAAs) using the INCRAFT AAA Stent Graft System was safe and effective in regulatory approval studies. We herein report on the 1-year results of a real-world clinical study. Methods: The INSIGHT study is a multi-center, prospective, open label, post-approval study conducted to continually evaluate the safety and performance of the INCRAFT System. Between 2015 and 2016, 150 consecutive patients with AAA at 23 centers in Europe were treated with the device in routine clinical practice. The primary endpoint was freedom from major adverse events (MAEs), namely death, myocardial infarction, cerebrovascular accident, and renal failure, within 30 days of the index procedure. End point data were assessed by a core laboratory. The secondary end points included technical success at the conclusion of the procedure and clinical success. Results: All 150 patients studied (mean age, 73.6 ± 8.0 years; 89.3% men) met the primary end point without MAEs at 30-day follow-up. Technical success was achieved in 99.3% of patients without stent fractures at 30 days. Among the 146 patients eligible for 1-year follow-up, the MAE rate was 8.2% (ie, 12 patients suffered 13 MAEs: cerebrovascular accident in 8, myocardial infarction in 1, and 4 died, resulting in a 2.7% all-cause mortality rate). There were no reports of new onset renal failure requiring dialysis. Only 2.7% of patients had type I endoleak, and no type III endoleaks were identified through 1 year. The rate of clinical success at 1 year was 91.8%. Conclusions: The 1-year results of this multicenter real-world study underscore the safety and effectiveness of endovascular treatment of AAA with the INCRAFT System in routine clinical practice.
One-year results of the INSIGHT study on endovascular treatment of abdominal aortic aneurysms / Torsello, G.; Bertoglio, L.; Kellersmann, R.; Wever, J. J.; van Overhagen, H.; Stavroulakis, K.; Becquemin, J. -P.; Buhler, C.; Chiesa, R.; Cieri, E.; Coppi, G.; de Blas, M.; Dias, N.; Ducasse, E.; Garcia, I.; Hamady, M.; Ippoliti, A.; Knippenberg, B.; Kolvenbach, R.; Lakshminarayan, R.; Lorido, A.; Midy, D.; Mosquera, N.; Oberhuber, A.; Pogany, G.; Pratesi, C.; Resch, T.; Riambau, V.; Roos, H.; Philipp Schafer, J.; Scheinert, D.; Silingardi, R.; Sultan, S.; Verzini, F.; Vona, A.; Warle, M.; Wikkeling, M.; Wilkins, J.. - In: JOURNAL OF VASCULAR SURGERY. - ISSN 0741-5214. - 75:6(2022), pp. 1904-1911. [10.1016/j.jvs.2021.12.066]