Evaluation of DeltaMaxx® Microcoil System in Intracranial Aneurysms
NCT ID: NCT01945827
Last Updated: 2014-07-03
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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WITHDRAWN
OBSERVATIONAL
2014-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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DeltaMaxx treated Patients
DeltaMaxx Microcoil System
Interventions
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DeltaMaxx Microcoil System
Eligibility Criteria
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Inclusion Criteria
* Investigator intends to use DeltaMaxx Microcoil system during coiling procedure
* Investigator intends to use only Codman Neuro microcoils during coiling procedure
* Aneurysm size \[largest measurement from the cross sectional images to determine overall aneurysm size, not just the lumen\] ≥6 mm
* If ruptured aneurysm: Hunt and Hess 1, 2, or 3
* If unruptured aneurysm: Subject grade Modified Rankin Scale 0 - 2
* The subject or his/her Legally Authorized Representative must voluntarily provide Informed Consent for participation in this study and agree to return for all study visits.
Exclusion Criteria
* Subjects with more than one aneurysm (\>2 mm) that have been treated with endovascular or clipping techniques in the past 30 days.
* Subject with social, medical or psychological conditions that interfere with treatment and follow-up evaluation
* Women who are pregnant or plan to become pregnant during the study
* Life expectancy less than 12 months.
* Presence of arteriovenous malformation
* Fusiform, mycotic, traumatic, or tumoral aneurysms
* Planned aneurysm treatment by parent vessel occlusion
* Subject enrolled in any concurrent study
18 Years
80 Years
ALL
No
Sponsors
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Codman & Shurtleff
INDUSTRY
Responsible Party
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Other Identifiers
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CD-000036-PRO
Identifier Type: -
Identifier Source: org_study_id
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