CARE: A Prospective Multicenter Case Study to Assess Radiation Exposure in Patients Treated With the Penumbra Coil 400

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

67 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-10-19

Brief Summary

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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 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.

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Detailed Description

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Conditions

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Intracranial Aneurysms

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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PC 400

Patients treated with the PC 400 according to the IFU

PC 400

Intervention Type DEVICE

Conventional Embolic Coils

These are any approved embolic coils on the market used as part of the standard of care for treating intracranial aneurysms.

PC 400

Intervention Type DEVICE

Interventions

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PC 400

Intervention Type DEVICE

Eligibility Criteria

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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.