Neuroform Atlas Stent for Intracranial Aneurysm Treatment

Completed

• Conditions: Intracranial Aneurysm

• Registration Number: NCT02783339
• Lead Sponsor: Stryker Neurovascular

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.

Study Timeline

• Study First Submitted: 2016-05-23
• Study First Submitted QC: 2016-05-25
• Study First Posted: 2016-05-26
• Study Start: 2016-09
• Primary Completion: 2020-07
• Study Completion: 2020-07
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-27
• Last Update Posted: 2020-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Subarachnoid hemorrhage rate	16 months
New or worsening major ipsilateral stroke as measured by NIHSS and mRS	16 months
Complete aneurysm occlusion rate of the treated target lesion on 16 month imaging	16 months	Measured by the Raymond Scale Class 1,2,3 with imaging at 12 to 16 months
Aneurysm Rupture rate	16 months

Trial Locations

Locations (11)

CHU Pellegrin; 🇫🇷 Bordeaux, France

CHU Hôpital cavale Blanche; 🇫🇷 Brest, France

CHU Bretonneau; 🇫🇷 Tours, France

Hôpital Gui de Chauliac; 🇫🇷 Montpellier, France

CHU Lariboisière; 🇫🇷 Paris, France

Klinikum Augsburg; 🇩🇪 Augsburg, Germany

HELIOS Klinikum Berlin-Buch; 🇩🇪 Berlin, Germany

Universitätsklinikum Knappschaftskrankenhaus Bochum; 🇩🇪 Bochum, Germany

Universität zu Lübeck; 🇩🇪 Lübeck, Germany

La Fondation Rothschild; 🇫🇷 Paris, France

Univerzitná nemocnica Martin; 🇸🇰 Martin, Slovakia