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

Evaluation of the LEO + Stent in the Endovascular Treatment of Wide Neck Intracranial Aneurysms (Fusiform, Saccular or Dissecting), Ruptured or Not Ruptured: Cohort of the Self-expanding Intracranial Stent LEO

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03504436

Enrollment

176

Registered

2018-04-20

Start date

2015-03-15

Completion date

2019-01-07

Last updated

2020-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Aneurysm

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.

Interventions

DEVICELEO +

LEO +: self-expanding intracranial stent

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026