Introduction The Surpass™ Flow Diverter (FD) was developed to treat large or giant wide-neck intracranial (IC) aneurysms not amenable to surgical or current standard endovascular treatment due to location, morphology or known treatment challenges. Compared to commercially available flow diversion technology in the US, the Surpass FD offers additional treatment options that fulfill an unmet clinical need as currently available flow diverter technology is limited to IC aneurysms within the ICA from the petrous to the superior hypophyseal segments. The Surpass FD’s Indications for Use allow for placement in the ICA up to the terminus. The Surpass FD is available in diameters from 3 to 5 mm and lengths of 15 to 50 mm, therefore allowing fewer Surpass FD use in the treatment of large and giant aneurysms. The goal of the present study is to present 3-year outcomes of SCENT Trial in special safety and efficacy of this large prospective cohort.
Methods The SCENT Trial is an international, multi-center, prospective, single arm trial designed to evaluate the safety and efficacy of the Surpass™ FD in treatment of large or giant wide-neck (≥4mm) IC aneurysms ≥10mm in size. We present 36-month outcome data. Secondary effectiveness endpoints measured post-index procedure through 60 months: the percent of aneurysm rupture, Surpass implant stenosis (≥50% stenosis), Parent artery occlusion at the target aneurysm location, change in mRS compared to baseline, Surpass delivered to cover the aneurysm neck, Raymond Class and complete occlusion at 36 months, Surpass successfully delivered and implanted, Incidence of retreatment at 36 months.
Results From October 2012 through November 2015, 180 subjects were treated at 26 sites. 36-month follow up, 94.8% (127/134) completed clinical follow-up, 76.9% (103/134) completed clinical and angiogram follow-up. The functional mRS scores remained unchanged or improved in most subjects at 36 months (85.0%, 108/127) when compared to the same measure at baseline. The rate of Raymond 1 total occlusion continued to improve at 36-month follow up compared to 12-month scores; 79.0% (83/105) of subjects demonstrated Raymond 1 occlusion at 36 months vs. 66.1% (119/180) at 12 months. Raymond 2 occlusion at 36 months was 20.0% (21/105), compared to 9.4% (17/180) of subjects with Raymond 2 at 12 months. The Raymond 3 occlusion rate decreased to 1.0% (1/105) of subjects at 36 months compared to 15.0% (27/180) 12-months post procedure. The proportion of subjects experiencing new or worsening major ipsilateral stroke, as adjudicated by the CEC, was 8.3% (15/180) at 12 months and increased to 8.8% (16/180) and 9.4% (17/180) subjects at 24, and 36 months respectively. Four (2.2%, 4/180) experienced aneurysm rupture by 12 months, all within the first-week post target aneurysm treatment. No additional late aneurysm ruptures occurred through 36 months. Four subjects who received retreatment beyond 12 months had a residual aneurysm. The 60-month occlusion durability and safety endpoint results will be the subject of a future presentation.
Disclosures R. Hanel: 1; C; Stryker, Medtronic, MicroVention, Balt. 2; C; Stryker, Medtronic, Balt, MicroVention, Phenox, Three Rivers Medical, Elum, Corindus, Shape Medical. 4; C; elum, Three Rivers Medical, Corindus, Cerebrotech, Synchron, BlinkTBI, Scientia, RIST, InNeuroCo. A. Coon: 2; C; stryker, medtronic, microvention, inneuroco. P. Kan: 2; C; Inneuroco. A. Wakhloo: 1; C; Phillips. 2; C; Stryker, Phenox. 4; C; Inneuroco, EPIEP, Neural Analytics. P. Meyers: 2; C; Stryker.
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