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Neuroform Atlas Stent System Study — ATLAS  

Intracranial Aneurysm Clinical Trial

Official title:
Safety and Effectiveness of the Treatment of Wide Neck, Intracranial, Saccular Aneurysms With the Next Generation Neuroform Stent System

Clinical Trial Summary

The primary objective of this study is to demonstrate effectiveness and safety of the Neuroform Atlas Stent System for use with bare metal embolic coils.

Clinical Trial Description

The study is a prospective, multicenter, open-label, single arm trial designed to demonstrate the potential treatment of wide neck, intracranial, saccular aneurysms with the Next Generation Neuroform Stent System with any approved embolic coils currently on the market. The study will evaluate the percent occlusion of the treated target lesion on angiography in the absence of retreatment, or parent artery stenosis at the target location at 12 months. Subjects with documented wide neck, intracranial, saccular aneurysms arising from a parent artery may potentially benefit from stent assisted coiling, provided they meet the other eligibility criteria. Data collected through the 12-month follow-up visit are intended to support Premarket Approval (PMA) application to the Food and Drug Administration (FDA). Long-term follow-up data collected through 3 years postoperative are intended to support post-approval study (PAS) requirements. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02340585
Study type Interventional
Source Stryker Neurovascular
Contact
Status Completed
Phase N/A
Start date June 18, 2015
Completion date September 30, 2022
View Details
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