Five-year results of the INSPIRATION study for the INCRAFT low-profile endovascular aortic stent graft system

• Published in: Journal of vascular surgery Vol. 73; no. 3; pp. 867 - 873.e2
• Main Authors: Liang, Nathan L., Ohki, Takao, Ouriel, Kenneth, Teigen, Corey, Fry, Dennis, Henretta, John, Komori, Kimihiro, Kichikawa, Kimihiko, Makaroun, Michel S.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01-03-2021
• Subjects: Abdominal aortic aneurysm; Aortic endograft; Endovascular aneurysm repair; INCRAFT; Low profile; Endovascular aneurysm repair; Aortic endograft; INCRAFT; Low profile; Abdominal aortic aneurysm
• ISSN: 0741-5214; 1097-6809
• DOI: 10.1016/j.jvs.2020.06.128

We present the 5-year results of a prospective regulatory study of the INCRAFT device, a low-profile endovascular stent graft system for repair of abdominal aortic aneurysms.
This was an open-label prospective nonrandomized single-arm study enrolling in centers in the United States and Japan. The primary effectiveness outcome was successful aneurysm treatment and the primary safety outcome was the incidence of major adverse events at 30 days after the procedure. Major long-term outcomes were mortality, reintervention, adverse limb outcomes, and suprarenal stent fracture.
One hundred and ninety patients (mean age, 73.8 ± 7.6 years; 90% male; 69% white and 30% Asian) were enrolled from 32 centers throughout the United States and Japan. Minimal access vessel size was less than 7 mm on both sides in 43.9% of the study cohort. Thirty-day major adverse events occurred in 3.2% of patients (6/190). Periprocedural technical success was 94.1% (176/187). Successful aneurysm treatment was 100% at 30 days and 87.9% at 1 year. Two patients required open conversion for thromboembolic complications, 3 developed new type I or III endoleaks, and 7 experienced graft or limb occlusion. Freedom from graft occlusion was 96 ± 2% at 1 year and 94 ± 2% at 5 years. Freedom from stent fracture was 97 ± 1% at 1 year and 87 ± 3% at 5 years. Freedom from aneurysm-related mortality was 99 ± 1% at 1 and 5 years.
This study demonstrates good efficacy and safety and a very low rate of aneurysm related deaths with the INCRAFT device in a population with a high proportion of challenging anatomy.