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.
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 Type
OBSERVATIONAL
Enrollment
105
CHU Pellegrin
Bordeaux, France
CHU Hôpital cavale Blanche
Brest, France
Hôpital Gui de Chauliac
Montpellier, France
CHU Lariboisière
Paris, France
permanent morbidity rate defined as any major ipsilateral stroke or neurolgocial death within 12 to 16 months following the procedure
Time frame: 16 Months
mortality rate within 12 to 16 months following the procedure
Time frame: 16 Months
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
Time frame: 16 months
New or worsening major ipsilateral stroke as measured by NIHSS and mRS
Time frame: 16 months
Subarachnoid hemorrhage rate
Time frame: 16 months
Aneurysm Rupture rate
Time frame: 16 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
La Fondation Rothschild
Paris, France
CHU Bretonneau
Tours, France
Klinikum Augsburg
Augsburg, Germany
HELIOS Klinikum Berlin-Buch
Berlin, Germany
Universitätsklinikum Knappschaftskrankenhaus Bochum
Bochum, Germany
Universität zu Lübeck
Lübeck, Germany
...and 1 more locations