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NCT03504436 Clinical Trial

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

Intracranial Aneurysm Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03504436
Other study ID # LEO + II
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 15, 2015
Est. completion date January 7, 2019

Study information
Verified date April 2018
Source Balt Extrusion
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 176
Est. completion date January 7, 2019
Est. primary completion date January 7, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• LEO +
LEO +: self-expanding intracranial stent

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Balt Extrusion

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary Morbi-mortality Number of complications and/or device or procedure related adverse events 18 months
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