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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.
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.
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Registration of patients who are willing to participate in this ATLAS PMCF registry and assuming they meet all of the inclusion/exclusion criteria and provided written informed consent should be recorded prior to implantation of the Neuroform Atlas Stent to ensure data capture on all enrolled and treated patients in this post-market evaluation.
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| Name | Affiliation | Role |
|---|---|---|
| Emmanuel Houdart, MD, PhD | Hopital Lariboisière | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Pellegrin | Bordeaux | F-33000 | France | |||
| CHU Hôpital cavale Blanche |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34475253 | Derived | Lefevre PH, Schramm P, Kemmling A, Barreau X, Marnat G, Piotin M, Berlis A, Wanke I, Bonafe A, Houdart E; ATLAS EU PMCF Investigators. Multi-centric European post-market follow-up study of the Neuroform Atlas Stent System: primary results. J Neurointerv Surg. 2022 Jul;14(7):694-698. doi: 10.1136/neurintsurg-2021-017849. Epub 2021 Sep 2. |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 16 months |
| Subarachnoid hemorrhage rate | 16 months |
| Aneurysm Rupture rate | 16 months |
| Brest |
| 29200 |
| France |
| Hôpital Gui de Chauliac | Montpellier | F-34295 | France |
| CHU Lariboisière | Paris | F-75010 | France |
| La Fondation Rothschild | Paris | F-75010 | France |
| CHU Bretonneau | Tours | 37000 | France |
| Klinikum Augsburg | Augsburg | D-86156 | Germany |
| HELIOS Klinikum Berlin-Buch | Berlin | D-13125 | Germany |
| Universitätsklinikum Knappschaftskrankenhaus Bochum | Bochum | D-44892 | Germany |
| Universität zu Lübeck | Lübeck | DE-23538 | Germany |
| Univerzitná nemocnica Martin | Martin | SL-036 01 | Slovakia |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |