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Neuroform Atlas Stent for Intracranial Aneurysm Treatment — ATLAS EU PMCF  

Intracranial Aneurysm Clinical Trial

Official title:
Evaluation of Safety and Performance of the Neuroform AtlasTM Stent System for Intracranial Aneurysm Treatment - Post Market Clinical Follow-up

Clinical Trial Summary

The primary objective of this study is to demonstrate effectiveness and safety of the NeuroForm Atlas stent system for use in patients requiring stent assisted intracranial aneurysm treatment.

Clinical Trial Description

The study is a prospective, multicenter, open-label, single arm post market follow-up registry designed to demonstrate the potential treatment of intracranial, saccular aneurysms with the Next Generation Neuroform Stent System. The study will evaluate the permanent morbidity and mortality rate within the 12 to 16 months following the procedure. The study will evaluate as well 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 to 16 months. Subjects with documented saccular aneurysms arising from a parent artery may potentially benefit from stent assisted coiling, provided they meet the other eligibility criteria. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02783339
Study type Observational [Patient Registry]
Source Stryker Neurovascular
Contact
Status Completed
Phase
Start date September 2016
Completion date July 2020
View Details
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