Neuroform Atlas Stent for Intracranial Aneurysm Treatment
ATLAS EU PMCF
Evaluation of Safety and Performance of the Neuroform AtlasTM Stent System for Intracranial Aneurysm Treatment - Post Market Clinical Follow-up
1 other identifier
observational
105
3 countries
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2016
Longer than P75 for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2016
CompletedFirst Posted
Study publicly available on registry
May 26, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedAugust 28, 2020
August 1, 2020
3.8 years
May 23, 2016
August 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Complete aneurysm occlusion rate of the treated target lesion on 16 month imaging
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
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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 -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
CHU Pellegrin
Bordeaux, F-33000, France
CHU Hôpital cavale Blanche
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
Related Publications (1)
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.
PMID: 34475253DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emmanuel Houdart, MD, PhD
Hopital Lariboisière
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 16 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2016
First Posted
May 26, 2016
Study Start
September 1, 2016
Primary Completion
July 1, 2020
Study Completion
July 1, 2020
Last Updated
August 28, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share