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

NCT ID: NCT03504436

Last Updated: 2020-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

176 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-15

Study Completion Date

2019-01-07

Brief Summary

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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

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Conditions

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Intracranial Aneurysm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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LEO +

LEO +: self-expanding intracranial stent

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Balt Extrusion

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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LEO + II

Identifier Type: -

Identifier Source: org_study_id

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