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

Stopped early

Conditions studied: Intracranial Aneurysms

In brief

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.

Key facts

Study ID

NCT02122133

Run by

Penumbra Inc.

People needed

67

Starts

2015-05-01

Expected to finish

2016-10-19

Last updated by the study team

2019-04-12

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Pre-planned use of multiple coil systems and/or flow diverters.

Where it is running

• Overlake Hospital Medical Center — Bellevue, Washington, United States

Full record on ClinicalTrials.gov

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