Clinical trial NCT02783339: Neuroform Atlas Stent for Intracranial Aneurysm Treatment
Official title: Evaluation of Safety and Performance of the Neuroform AtlasTM Stent System for Intracranial Aneurysm Treatment - Post Market Clinical Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Aneurysm
Keywords: Next Generation Neuroform Stent System
Intracranial
Stent system
Saccular aneurysm
Stent assisted coiling
Lead sponsor: Stryker Neurovascular
Sponsor class: INDUSTRY
First posted: 2016-05-26
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Patient has an intracranial aneurysm for which an endovascular treatment requiring stent assisted intracranial aneurysm coiling has been decided by the site investigator
2. Patient or legal representative is willing and able to provide written informed consent
3. Patient is willing able to comply with scheduled visits and examinations per protocol requirements

Exclusion Criteria:

1. Patient that is younger than 18 years old at the time of entry into the study
2. Patient with mRS \> 3
3. Patient has a saccular ruptured aneurysm \< 3 months
4. Patient has a fusiform aneurysm
5. Treatment of several aneurysms during the same procedure, except adjacent aneurysms treated with the same stent
6. Planned treatment of other aneurysm in the same vascular territory within the study time period
7. Patient with severe vasospasm that does not respond to pharmacological therapy
8. Aneurysm associated with an arteriovenous malformation, or any other lesion that could lead to hemorrhagic complications
9. Pregnant woman or child feeding
10. Any condition which will not allow the patient to comply with the necessary follow-up for this study (medical condition, patient leaving abroad)
11. Patient with confirmed allergy to nickel titanium (Nitinol)
12. Patient in whom antiplatelet and/or anticoagulation therapy is contraindicate
13. 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
14. Patient for whom angiography and MRA/MRI is contraindicated
15. Patient with target aneurysm previously treated with a stent -

Primary outcomes:
measure: permanent morbidity rate defined as any major ipsilateral stroke or neurolgocial death within 12 to 16 months following the procedure
timeFrame: 16 Months
measure: mortality rate within 12 to 16 months following the procedure
timeFrame: 16 Months
Secondary outcomes:
measure: Complete aneurysm occlusion rate of the treated target lesion on 16 month imaging
timeFrame: 16 months
measure: New or worsening major ipsilateral stroke as measured by NIHSS and mRS
timeFrame: 16 months
measure: Subarachnoid hemorrhage rate
timeFrame: 16 months
measure: Aneurysm Rupture rate
timeFrame: 16 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Pellegrin
city: Brest
country: France
facility: CHU Hôpital cavale Blanche
city: Montpellier
country: France
facility: Hôpital Gui de Chauliac
city: Paris
country: France
facility: CHU Lariboisière
city: Paris
country: France
facility: La Fondation Rothschild
city: Tours
country: France
facility: CHU Bretonneau
city: Augsburg
country: Germany
facility: Klinikum Augsburg
city: Berlin
country: Germany
facility: HELIOS Klinikum Berlin-Buch
city: Bochum
country: Germany
facility: Universitätsklinikum Knappschaftskrankenhaus Bochum
city: Lübeck
country: Germany
facility: Universität zu Lübeck
city: Martin
country: Slovakia
facility: Univerzitná nemocnica Martin
Study officials:
affiliation: Hopital Lariboisière
name: Emmanuel Houdart, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.