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

Intracranial Aneurysms Clinical Trial

— CARE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02122133
• Other study ID #: CLP 7495
• Status: Terminated
• Start date: May 2015
• Est. completion date: October 19, 2016

Study information

• Verified date: April 2019
• Source: Penumbra Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 67
• Est. completion date: October 19, 2016
• Est. primary completion date: October 19, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Intracranial Aneurysms

Intervention

Device:
• PC 400

Locations

Country	Name	City	State
United States	Overlake Hospital Medical Center	Bellevue	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Penumbra Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. Acute radiation exposure [air kerma, kerma-area product (KAP) or dose area product (DAP), and fluoroscopic time].	Radiation exposure is measured by air kerma, kerma-area product (KAP) or dose area product (DAP), and fluoroscopic time.	At immediate post-procedure
Primary	2. Procedural serious adverse events		Procedural serious adverse events up until 3 days or discharge, whichever occurs first.