Status:
COMPLETED
Flow Diverter Stent for Endovascular Treatment of Unruptured Saccular Wide-necked Intracranial Aneurysms
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Intracranial Aneurysm
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Unruptured saccular intracranial aneurysms larger than 7 mm can be treated with endovascular occlusion using detachable coils, with or without expendable stent assistance. A new endovascular technique...
Detailed Description
Main Outcome Measure: Percentage of patients with an aneurysm with complete occlusion, defined as the absence of visible blood flow to the consideration of angiography performed 12 months post-endovas...
Eligibility Criteria
Inclusion
- Patient's age ≥ 18 years old
- Unruptured saccular intracranial aneurysm diagnosed by angiography or CT angiography or MR angiography, located in the intra-dural area, with a neck diameter between 4 and 10 mm, with a sac diameter between 7 mm and 20 mm, with a ratio "dome/nek" greater than 1, and with a diameter of the parent artery between 2 and 5 mm.
- No prior treatment of the aneurysm
- Agreement for participating in the study and informed consent signed by the patient
- Patient affiliated to a social security scheme
Exclusion
- Patient's age \< 18 years old
- Adult patient protected by law
- Contraindications to the endovascular procedure
- Contraindications to antiplatelet or anticoagulant treatment
- Prior treatment of the aneurysm
- Presence of an arteriovenous malformation
- Extradural location of the aneurysm
- Fusiform aneurysm
- Active bacterial infection (clinical signs)
- Intracranial hemorrhage from aneurysm in the previous month
- Pregnant or breastfeeding woman
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2020
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT01811134
Start Date
November 1 2012
End Date
March 1 2020
Last Update
December 19 2025
Active Locations (1)
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1
Hospices Civils de Lyon
Lyon, BRON, France