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



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:4/21/2016
Start Date:May 2015
End Date:December 2016
Contact:Abhineet Chowdhary, MD
Email:minkuc@gmail.com

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Trial Summary
Trial Overview
Inclusion Criteria

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

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.


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.
We found this trial at
1
site
Overlake Hospital Medical Center
Bellevue, Washington 98004
Principal Investigator: Abhineet Chowdhary, MD
Phone: 425-635-6300
?
mi
from
Bellevue, WA
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