A Volumetric Coiling in Aneurysm Registry of the Penumbra Coil 400TM System
NCT ID: NCT01754051
Last Updated: 2018-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2013-01-31
2017-10-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Treatment by the PC 400 coils
Patients enrolled in this study must be those treated according to the cleared indication for the PC 400 System in the Instructions for Use.
PC 400 coils
Interventions
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PC 400 coils
Eligibility Criteria
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Inclusion Criteria
* Intracranial aneurysms \>2mm, ruptured or unruptured
Exclusion Criteria
* Dissecting aneurysms
* Aneurysms associated with brain AVMs
* Multiple aneurysms
* Re-treated aneurysms
* Patients in whom endovascular embolization therapies other than PC 400 System are used will be excluded from this study. However, adjunctive use of balloon and stent are acceptable.
18 Years
ALL
No
Sponsors
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Penumbra Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Dr. Jérôme Berge, MD
Role: PRINCIPAL_INVESTIGATOR
CHU Pellegrin - Bordeaux
Locations
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CHU Pellegrin
Bordeaux, , France
Countries
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Other Identifiers
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CLP 4818
Identifier Type: OTHER
Identifier Source: secondary_id
CLP 4818
Identifier Type: -
Identifier Source: org_study_id
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