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

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.

Study Overview

• Status: Completed
• Conditions: Intracranial Aneurysm

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.

• Study Type: Observational
• Enrollment (Anticipated): 105

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, F-33000
    • CHU Pellegrin
  • Brest, France, 29200
    • CHU Hôpital cavale Blanche
  • Montpellier, France, F-34295
    • Hopital Gui de Chauliac
  • Paris, France, F-75010
    • CHU Lariboisière
  • Paris, France, F-75010
    • La Fondation Rothschild
  • Tours, France, 37000
    • CHU Bretonneau
• Germany
  • Augsburg, Germany, D-86156
    • Klinikum Augsburg
  • Berlin, Germany, D-13125
    • Helios Klinikum Berlin-Buch
  • Bochum, Germany, D-44892
    • Universitätsklinikum Knappschaftskrankenhaus Bochum
  • Lübeck, Germany, DE-23538
    • Universität zu Lübeck
• Slovakia
  • Martin, Slovakia, SL-036 01
    • Univerzitna nemocnica Martin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 -

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Stryker Neurovascular
• Investigators: Principal Investigator: Emmanuel Houdart, MD, PhD, Hopital Lariboisiere

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: May 23, 2016
• First Submitted That Met QC Criteria: May 25, 2016
• First Posted (Estimate): May 26, 2016

Study Record Updates

• Last Update Posted (Actual): August 28, 2020
• Last Update Submitted That Met QC Criteria: August 27, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Next Generation Neuroform Stent System; Intracranial; Stent system; Saccular aneurysm; Stent assisted coiling
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: T4032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No