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Intracranial AneurysmATLAS EU PMCFNCT02783339

Neuroform Atlas Stent for Intracranial Aneurysm Treatment

An observational study of Intracranial Aneurysm, run by Stryker Neurovascular at 11 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intracranial Aneurysm
How many people
105 participants
Where
11 sitesin 3 countries
Study dates
Sep 2016to Jul 2020
How long will I take part?
16 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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 -

Trial locations and contacts

11 sites in 3 countries.

11 sites in 3 countries

France6 sites

  • CHU Pellegrin

    Bordeaux, F-33000

  • CHU Hôpital cavale Blanche

    Brest, 29200

  • Hôpital Gui de Chauliac

    Montpellier, F-34295

  • CHU Lariboisière

    Paris, F-75010

  • La Fondation Rothschild

    Paris, F-75010

  • CHU Bretonneau

    Tours, 37000

Other trials in France

Germany4 sites

  • Klinikum Augsburg

    Augsburg, D-86156

  • HELIOS Klinikum Berlin-Buch

    Berlin, D-13125

  • Universitätsklinikum Knappschaftskrankenhaus Bochum

    Bochum, D-44892

  • Universität zu Lübeck

    Lübeck, DE-23538

Other trials in Germany

Slovakia1 site

  • Univerzitná nemocnica Martin

    Martin, SL-036 01

Other trials in Slovakia

About this study

Official title: 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.

Read the 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.

Keywords
Next Generation Neuroform Stent System, Intracranial, Stent system, Saccular aneurysm, Stent assisted coiling
Medical subject headings
Intracranial Aneurysm, Aneurysm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. permanent morbidity rate defined as any major ipsilateral stroke or neurolgocial death within 12 to 16 months following the procedure

    Measured: 16 Months

  2. mortality rate within 12 to 16 months following the procedure

    Measured: 16 Months

Secondary outcomes (4)

  1. 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

    Measured: 16 months

  2. New or worsening major ipsilateral stroke as measured by NIHSS and mRS

    Measured: 16 months

  3. Subarachnoid hemorrhage rate

    Measured: 16 months

  4. Aneurysm Rupture rate

    Measured: 16 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionJul 2020
  4. Study completionJul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
105 participants (estimated)
Target duration
16 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT02783339
Sponsor's protocol ID
T4032
Acronym
ATLAS EU PMCF
Status last verified
Aug 2020
First submitted
23 May 2016
Last updated
28 Aug 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

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.

    PubMed 34475253

Questions about this trial

What is this clinical trial studying?

An observational study of Intracranial Aneurysm, run by Stryker Neurovascular at 11 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in France, Germany, Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

permanent morbidity rate defined as any major ipsilateral stroke or neurolgocial death within 12 to 16 months following the procedure (time frame: 16 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02783339, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2020.

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