A Volumetric Coiling in Aneurysm Registry of the Penumbra Coil 400TM System
Completed
- Conditions
- Intracranial Aneurysms
- Registration Number
- NCT01754051
- Lead Sponsor
- Penumbra Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time of fluoroscopic exposure During the procedure Packing density with the number of coils implanted During the procedure Quality of aneurysm occlusion post-operatively and at 12±3 months post-procedure based on the Raymond Scale At 1 year post-procedure Procedural device-related serious adverse events at immediate post-procedure During the procedure
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
CHU Pellegrin
🇫🇷Bordeaux, France
CHU Pellegrin🇫🇷Bordeaux, France