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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03504436
Recruitment Status : Active, not recruiting
First Posted : April 20, 2018
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
Balt Extrusion

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.

Condition or disease Intervention/treatment
Intracranial Aneurysm Device: LEO +

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Study Type : Observational [Patient Registry]
Actual Enrollment : 176 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 18 Months
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
Actual Study Start Date : March 15, 2015
Estimated Primary Completion Date : February 12, 2019
Estimated Study Completion Date : February 12, 2019

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. 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

  2. Morbi-mortality [ Time Frame: 18 months ]
    Number of complications and/or device or procedure related adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with ruptured or not ruptured intracranial aneurysms demonstrated by cerebral arteriography treated with LEO + stent
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.

Additional Information:

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Responsible Party: Balt Extrusion
ClinicalTrials.gov Identifier: NCT03504436     History of Changes
Other Study ID Numbers: LEO + II
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Intracranial Aneurysm
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases