Endovascular Treatment of Wide Neck Intracranial Aneurysm... | NCT03504436

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

NCT03504436

Sponsor

Balt Extrusion

Status

Completed

Last Update Posted

Jan 7, 2020Actual

Enrollment

176Actual

Phase

Not provided

Conditions

Intracranial Aneurysm

Interventions

LEO +

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 15, 2015Actual

Primary Completion Date

Jan 7, 2019Actual

Completion Date

Jan 7, 2019Actual

First Submitted Date

Apr 12, 2018

First Submission Date that Met QC Criteria

Apr 19, 2018

First Posted Date

Apr 20, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 6, 2020

Last Update Posted Date

Jan 7, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

18 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

176Actual

Name	Type	Description	Arm Group Labels	Other Names
LEO +	Device	LEO +: self-expanding intracranial stent

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002532	Intracranial Aneurysm

Ancestor Terms

ID	Term
D020765	Intracranial Arterial Diseases
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided