Abstract WMP36: Surpass™ IntraCranial Aneurysm EmbolizatioN System Pivotal Trial to Treat Large OR Giant Wide Neck Aneurysms (SCENT Trial): One Year Outcomes

Abstract

Introduction: Surpass™ Flow Diverter was developed to treat large or giant wide-neck intracranial aneurysms (IA) not amenable to surgical or current standard endovascular treatment due to location, morphology, or known treatment challenges. FDA approved on July 13 2018, Surpass™ fulfills an unmet clinical need. Indications for Use allow for placement in the entire intracranial internal carotid artery (ICA). Surpass™ is available in diameters of 3 to 5 mm and lengths of 15 to 50 mm. Methods: SCENT Trial is an international, multi-center, prospective, non-randomized trial comparing the outcomes of Surpass™ Flow Diverter treatment to historical control. It is designed to evaluate the safety and efficacy of Surpass™ for treatment of wide-neck (≥4mm), large or giant IA ≥10 mm in size. The primary safety endpoint is the percent of subjects experiencing neurologic death or major ipsilateral stroke at 12 months. The primary effectiveness endpoint is the percent of subjects with 100% occlusion (Raymond Class 1) without clinically significant stenosis (≤50% stenosis) of the parent artery, and any retreatment of the target aneurysm at 12-month. Results: From 2012 to 2015, 180 subjects were treated at 26 sites. Mean age was 61.0 years and 91.7% (165/180) were females. Aneurysms were most frequently located in the carotid-ophthalmic segment (33.3%; 60/180), followed by the cavernous segment (28.9%; 52/180), posterior communicating artery (21.1%; 38/180), supraclinoid carotid artery (11.1%; 20/180), superior hypophyseal artery (3.3%; 6/180), and the petrous segment (2.2%; 4/180). Mean aneurysm dimension included dome height 13.4±5.7 mm. Mean neck width was 6.7 mm. Technical success occurred in 97.8% (176/180) of subjects while the mean number of Surpass™ devices used was 1.1 per procedure, with 86.7% (156/180) of aneurysms treated with a single flow diverter. The 12-month primary effectiveness rate was 62.8% [(113/180), 95% CI 55.3, 69.9] and 12-month major ipsilateral stroke or neurological death rate of 10.6% [(19/180), 95% CI 55.3, 69.9] Conclusions: Surpass™ Flow Diverter is safe and effective to treat large and giant aneurysms intracranial internal carotid aneurysms.