Intracranial Aneurysms
Conditions
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.
Interventions
DEVICEPC 400 coils
Sponsors
Penumbra Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Packing density with the number of coils implanted | During the procedure |
| Time of fluoroscopic exposure | During the procedure |
| Procedural device-related serious adverse events at immediate post-procedure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Acute occlusion of the aneurysm sac at immediate post-procedure | At immediate post-procedure |
| Adverse events occurring during the procedure and in the 30±7 days following the treatment. | During and at 30 days post-procedure |
Countries
France
Outcome results
None listed