The primary objective of this study is to evaluate the safety and effectiveness of the Surpass™ Evolve Flow Diverter System in the treatment of unruptured, wide-neck intracranial aneurysms measuring ≤ 12 mm and located on the ICA or its branches
The Surpass Evolve Flow Diverter System is indicated for the endovascular treatment of adults (age 18 or above) with unruptured saccular wide-neck or fusiform intracranial aneurysms ≤ 12 mm for treatment in vessel diameters between 1.75-5.0mm.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
248
The Surpass Evolve Flow Diverter System is indicated for the endovascular treatment of adults (age 18 or above) with unruptured saccular wide-neck or fusiform intracranial aneurysms ≤12 mm.
Primary Effectiveness Endpoint
The primary effectiveness endpoint of this study is a composite of 100% occlusion (Raymond 1, complete occlusion) of the target aneurysm without significant parent artery stenosis (\>50% stenosis), per independent core lab assessment of digital subtraction angiography (DSA) images acquired at 12 months (± 3 months) post-procedure, and with no target aneurysm retreatment.
Time frame: 12 months (± 3 months) post procedure
Primary Safety Endpoint
The primary safety endpoint of this study is neurologic death, or disabling stroke at 12 months as adjudicated by an independent Clinical Events Committee (CEC).
Time frame: 12 Months (± 3 months) post procedure
Secondary Safety Endpoints
The secondary safety endpoints will be evaluated throughout the study, and are as follows: 1. Neurological death or major ipsilateral stroke as adjudicated by an independent Clinical Events Committee. 2. Stroke in the treated vascular territory as adjudicated by a Clinical Events Committee
Time frame: 3 Year Follow-Up
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