Endovascular Treatment of Wide Neck Intracranial Aneurysms With the LEO + Stent : The LEO + II Cohort Study
Completed
- Conditions
- Intracranial Aneurysm
- Registration Number
- NCT03504436
- Lead Sponsor
- Balt Extrusion
- Brief Summary
This is a prospective, multicenter, single-arm observational study to evaluate the efficacy and the morbi-mortality of LEO + in patients with wide neck intracranial aneurysms (fusiform, saccular or dissecting), ruptured or not ruptured.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 176
Inclusion Criteria
- All patients with ruptured or not ruptured intracranial aneurysms demonstrated by cerebral arteriography treated with LEO + stent
- Patients (or their parents for minors) must be informed and give written consent
Exclusion Criteria
- Patients (or parents) who refused to give consent.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total aneurysmal occlusion rate 18 months Classification of the occlusion observed angiographically as "complete occlusion", "residual neck" or "residual aneurysm" using the Montreal three-grade scale
Morbi-mortality 18 months Number of complications and/or device or procedure related adverse events
- Secondary Outcome Measures
Name Time Method