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Business decision to focus on other studies. No safety concern.
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The primary objective of this study is to gather data on the radiation exposure in patients treated with the Penumbra Coil 400â„¢ System (PC 400) or conventional coils per their respective indications for use.This is a multicenter case review study of patients presenting with intracranial aneurysms who are treated with coil embolization therapy using the PC 400 or conventional coils. Data for each patient are collected acutely.Up to 90 patients treated with the PC 400 or conventional coils (2:1) at up to 15 centers in the USA will be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PC 400 | Patients treated with the PC 400 according to the IFU |
| |
| Conventional Embolic Coils | These are any approved embolic coils on the market used as part of the standard of care for treating intracranial aneurysms. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PC 400 | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1. Acute radiation exposure [air kerma, kerma-area product (KAP) or dose area product (DAP), and fluoroscopic time]. | Radiation exposure is measured by air kerma, kerma-area product (KAP) or dose area product (DAP), and fluoroscopic time. | At immediate post-procedure |
| 2. Procedural serious adverse events | Procedural serious adverse events up until 3 days or discharge, whichever occurs first. |
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Inclusion Criteria:
Exclusion Criteria:
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Up to 90 patients treated with the PC 400 or conventional coils (2:1) at up to 15 centers in the USA will be enrolled.
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| Name | Affiliation | Role |
|---|---|---|
| Abhineet Chowdhary, MD | Director of Neuro-Interventional Surgery, Overlake Hospital Medical Center, Bellevue, WA 98004 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Overlake Hospital Medical Center | Bellevue | Washington | 98004 | United States |
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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 |