Endovascular Treatment of Wide Neck Intracranial Aneurysms With the LEO + Stent : The LEO + II Cohort Study

Balt Extrusion176 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

176

Conditions

Intracranial Aneurysm

Interventions

LEO +DEVICE

LEO +: self-expanding intracranial stent

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Total aneurysmal occlusion rate

Classification of the occlusion observed angiographically as "complete occlusion", "residual neck" or "residual aneurysm" using the Montreal three-grade scale

Time frame: 18 months

Morbi-mortality

Number of complications and/or device or procedure related adverse events

Time frame: 18 months

Data from ClinicalTrials.gov

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