NCT01754051
Completed
Not Applicable
VOLCAN: A Volumetric Coiling in Aneurysm Registry of the Penumbra Coil 400TM System
ConditionsIntracranial Aneurysms
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Intracranial Aneurysms
- Sponsor
- Penumbra Inc.
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Time of fluoroscopic exposure
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This study is a prospective, multi-center registry of patients with intracranial aneurysms who are treated by the PC 400 System. Data for each patient are collected up to 12 ± 3 months post-procedure for the study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients older than 18 years
- •Intracranial aneurysms \>2mm, ruptured or unruptured
Exclusion Criteria
- •Fusiform aneurysms
- •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.
Outcomes
Primary Outcomes
Time of fluoroscopic exposure
Time Frame: During the procedure
Packing density with the number of coils implanted
Time Frame: During the procedure
Quality of aneurysm occlusion post-operatively and at 12±3 months post-procedure based on the Raymond Scale
Time Frame: At 1 year post-procedure
Procedural device-related serious adverse events at immediate post-procedure
Time Frame: During the procedure
Secondary Outcomes
- Adverse events occurring during the procedure and in the 30±7 days following the treatment.(During and at 30 days post-procedure)
- Acute occlusion of the aneurysm sac at immediate post-procedure(At immediate post-procedure)
Study Sites (1)
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