Background Large and giant intracranial aneurysms remain challenging lesions for endovascular treatment. The Surpass™ device is a braided endoprosthesis designed to achieve a precise delivery with a more uniform and consistent mesh configuration for flow diversion and treatment of intracranial aneurysms.
Methods The SCENT trial is an international multi-center, prospective, non-randomized trial comparing safety and efficacy outcomes of the Surpass Flow Diverter (Stryker Neurovascular, Fremont, CA) to a historical control used in the treatment of large or giant wide neck intracranial aneurysms. Eligible subjects are required to be 19 to 80 years of age, have a single targeted intracranial aneurysm that is located in the internal carotid artery (ICA) distribution up to the terminus with a neck ≥4 mm or no discernible neck and an aneurysm size ≥10 mm. (including saccular, fusiform and dissecting configuration). The primary safety end-point is the percent of subjects experiencing neurologic death or major ipsilateral stroke through 12 months. The primary effectiveness end-point is the percent of subjects with 100% occlusion (Raymond Class 1) without clinically significant stenosis (defined as < 50% stenosis) of the parent artery and without any subsequent treatment of the target aneurysm at 12 months.
Results 22 sites are currently enrolling and treating subjects (21 in the US, 1 in Europe). A total of 159 patients have been enrolled, with 149 treated (29 as roll-in subjects; 120 as protocol evaluable subjects).
Conclusion The SCENT trial is currently enrolling and is expected to complete enrollment by mid-2015.
Disclosures A. Puri: 1; C; Research grant from Stryker. 2; C; Codman and Covidien. R. Hanel: 2; C; Stryker, Codman and Covidien. 4; C; Blockade. 5; C; Scientific advisory board- Medina medical. P. Meyers: None.