Evaluation of DeltaMaxx® Microcoil System in Intracranial Aneurysms | NCT01945827 | Trialant
WithdrawnObservationalUpdated Jul 3, 2014
Evaluation of DeltaMaxx® Microcoil System in Intracranial Aneurysms
ClinicalTrials.gov ID
NCT01945827
Lead Sponsor
Codman & ShurtleffINDUSTRY
Overall Status
Withdrawn
Study Type
Observational
Enrollment
0Actual
Last Update Posted
Jul 3, 2014Estimated
Start Date
Jan 2014
Primary Completion Date
Dec 2014Estimated
Brief Summary
The primary objective of this registry is to assess the safety and angiographic outcomes of endovascular treatment of intracranial aneurysms using the DeltaMaxx Microcoil System.
Intracranial Aneurysms
DeltaMaxx Microcoil System
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject age ≥18 and ≤80 with a diagnosis of ruptured or unruptured intracranial aneurysm judged suitable for selective endovascular treatment by coil occlusion during single procedure
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
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:
Prior treatment (surgical or endovascular) of the target aneurysm
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