Intracranial Aneurysms
Conditions
Keywords
IC aneurysms, coil embolization, PC 400, radiation exposure,
Brief summary
The primary objective of this study is to gather data on the radiation exposure in patients treated with the Penumbra Coil 400™ 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.
Interventions
DEVICEPC 400
Sponsors
Penumbra Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients enrolled in the PC 400 arm must be those treated according to the cleared indication for the PC 400 System, which includes endovascular embolization of intracranial aneurysms. * Patients treated with conventional coils should be treated per their IFU. * Adjunctive use of stents, balloons or liquid embolics, if considered appropriate by investigators, is allowed.
Exclusion criteria
* Pre-planned use of multiple coil systems and/or flow diverters.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1. Acute radiation exposure [air kerma, kerma-area product (KAP) or dose area product (DAP), and fluoroscopic time]. | At immediate post-procedure | Radiation exposure is measured by air kerma, kerma-area product (KAP) or dose area product (DAP), and fluoroscopic time. |
| 2. Procedural serious adverse events | Procedural serious adverse events up until 3 days or discharge, whichever occurs first. | — |
Countries
United States
Outcome results
None listed