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| ID | Type | Description | Link |
|---|---|---|---|
| CLP 4818 | Other Identifier | Penumbra Inc |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment by the PC 400 coils | Patients enrolled in this study must be those treated according to the cleared indication for the PC 400 System in the Instructions for Use. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PC 400 coils | Device |
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| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Up to 200 patients with intracranial aneurysms treated by the PC 400 System at up to 20 centers will be enrolled.
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Jérôme Berge, MD | CHU Pellegrin - Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Pellegrin | Bordeaux | France |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |