Neuroform Atlas Stent for Intracranial Aneurysm Treatment

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Intracranial Aneurysm

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has an intracranial aneurysm for which an endovascular treatment requiring stent assisted intracranial aneurysm coiling has been decided by the site investigator Patient or legal representative is willing and able to provide written informed consent Patient is willing able to comply with scheduled visits and examinations per protocol requirements Exclusion Criteria: Patient that is younger than 18 years old at the time of entry into the study Patient with mRS > 3 Patient has a saccular ruptured aneurysm < 3 months Patient has a fusiform aneurysm Treatment of several aneurysms during the same procedure, except adjacent aneurysms treated with the same stent Planned treatment of other aneurysm in the same vascular territory within the study time period Patient with severe vasospasm that does not respond to pharmacological therapy Aneurysm associated with an arteriovenous malformation, or any other lesion that could lead to hemorrhagic complications Pregnant woman or child feeding Any condition which will not allow the patient to comply with the necessary follow-up for this study (medical condition, patient leaving abroad) Patient with confirmed allergy to nickel titanium (Nitinol) Patient in whom antiplatelet and/or anticoagulation therapy is contraindicate Patient for whom angiography and other examinations show that access to the target cerebral aneurysm by the stent may be impossible because of anatomical features Patient for whom angiography and MRA/MRI is contraindicated Patient with target aneurysm previously treated with a stent -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| permanent morbidity rate defined as any major ipsilateral stroke or neurolgocial death within 12 to 16 months following the procedure |  | 16 Months | 
| mortality rate within 12 to 16 months following the procedure |  | 16 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete aneurysm occlusion rate of the treated target lesion on 16 month imaging | Measured by the Raymond Scale Class 1,2,3 with imaging at 12 to 16 months | 16 months | 
| New or worsening major ipsilateral stroke as measured by NIHSS and mRS |  | 16 months | 
| Subarachnoid hemorrhage rate |  | 16 months | 
| Aneurysm Rupture rate |  | 16 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Next Generation Neuroform Stent System, Intracranial, Stent system, Saccular aneurysm, Stent assisted coiling