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E-070 the surpass intracranial aneurysm embolization system pivotal trial to treat large or giant wide neck aneurysms (scent trial)
  1. A Puri1,
  2. R Hanel2,
  3. P Meyers3
  1. 1Department of Radiology and Neurosurgery, Division Neuroimaging and Intervention, University of Massachusetts Medical School, Worcester, MA
  2. 2Department of Neurosurgery, Baptist Health System, Jacksonville, FL, USA
  3. 3Department of Radiology and Neurosurgery, Columbia University Medical Center, New York, NY, USA

Abstract

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.

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