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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Intracranial Aneurysm Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Arterial Diseases Nervous System Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LEO +

Device

LEO +: self-expanding intracranial stent

Primary outcomes

Total aneurysmal occlusion rate

Time frame: 18 months

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

Time frame: 18 months

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

Sponsors and collaborators

Lead sponsor

Balt Extrusion

Industry

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2019
Study completion: 2019
First posted: Apr 20, 2018
Registry last updated: Jan 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed