CARE: A Multicenter Case Study to Assess Radiation Exposure in Patients Treated With the Penumbra Coil 400
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Intracranial Aneurysms
- Sponsor
- Penumbra Inc.
- Enrollment
- 67
- Locations
- 1
- Primary Endpoint
- 1. Acute radiation exposure [air kerma, kerma-area product (KAP) or dose area product (DAP), and fluoroscopic time].
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
1. Acute radiation exposure [air kerma, kerma-area product (KAP) or dose area product (DAP), and fluoroscopic time].
Time Frame: 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
Time Frame: Procedural serious adverse events up until 3 days or discharge, whichever occurs first.