Neuroform Atlas Stent for Intracranial Aneurysm Treatment

Intracranial Aneurysm Clinical Trial

— ATLAS EU PMCF  

Official title:

Evaluation of Safety and Performance of the Neuroform AtlasTM Stent System for Intracranial Aneurysm Treatment - Post Market Clinical Follow-up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02783339
• Other study ID #: T4032
• Status: Completed
• Start date: September 2016
• Est. completion date: July 2020

Study information

• Verified date: August 2020
• Source: Stryker Neurovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 -

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

Locations

Country	Name	City	State
France	CHU Pellegrin	Bordeaux
France	CHU Hôpital cavale Blanche	Brest
France	Hôpital Gui de Chauliac	Montpellier
France	CHU Lariboisière	Paris
France	La Fondation Rothschild	Paris
France	CHU Bretonneau	Tours
Germany	Klinikum Augsburg	Augsburg
Germany	HELIOS Klinikum Berlin-Buch	Berlin
Germany	Universitätsklinikum Knappschaftskrankenhaus Bochum	Bochum
Germany	Universität zu Lübeck	Lübeck
Slovakia	Univerzitná nemocnica Martin	Martin

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Neurovascular

Countries where clinical trial is conducted

France,  Germany,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	permanent morbidity rate defined as any major ipsilateral stroke or neurolgocial death within 12 to 16 months following the procedure		16 Months
Primary	mortality rate within 12 to 16 months following the procedure		16 Months
Secondary	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
Secondary	New or worsening major ipsilateral stroke as measured by NIHSS and mRS		16 months
Secondary	Subarachnoid hemorrhage rate		16 months
Secondary	Aneurysm Rupture rate		16 months