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

Terminated

• Conditions: Intracranial Aneurysms
• Interventions: Device: PC 400

• Registration Number: NCT02122133
• Lead Sponsor: Penumbra Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-21
• Study First Submitted QC: 2014-04-22
• Study First Posted: 2014-04-24
• Study Start: 2015-05
• Primary Completion: 2016-10-19
• Study Completion: 2016-10-19
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-10
• Last Update Posted: 2019-04-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 67

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PC 400	PC 400	Patients treated with the PC 400 according to the IFU
Conventional Embolic Coils	PC 400	These are any approved embolic coils on the market used as part of the standard of care for treating intracranial aneurysms.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Overlake Hospital Medical Center; 🇺🇸 Bellevue, Washington, United States