NCT03504436

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2015

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2015

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

April 12, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 20, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2019

Completed
Last Updated

January 7, 2020

Status Verified

April 1, 2018

Enrollment Period

3.8 years

First QC Date

April 12, 2018

Last Update Submit

January 6, 2020

Conditions

Intracranial Aneurysm

Outcome Measures

Primary Outcomes (2)

  • Total aneurysmal occlusion rate

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

    18 months

  • Morbi-mortality

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

    18 months

Interventions

LEO +DEVICE

LEO +: self-expanding intracranial stent

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with ruptured or not ruptured intracranial aneurysms demonstrated by cerebral arteriography treated with LEO + stent

You may qualify if:

  • 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

You may not qualify if:

  • Patients (or parents) who refused to give consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
18 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2018

First Posted

April 20, 2018

Study Start

March 15, 2015

Primary Completion

January 7, 2019

Study Completion

January 7, 2019

Last Updated

January 7, 2020

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share