Intracranial Aneurysm
Conditions
Keywords
Next Generation Neuroform Stent System, Intracranial, Stent system, Saccular aneurysm, Stent assisted coiling
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.
Interventions
None listed
Sponsors
Stryker Neurovascular
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 -
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| New or worsening major ipsilateral stroke as measured by NIHSS and mRS | 16 months | — |
| Subarachnoid hemorrhage rate | 16 months | — |
| Aneurysm Rupture rate | 16 months | — |
Countries
France, Germany, Slovakia
Outcome results
None listed