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

Sponsor

Penumbra Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT02122133

Collaborator

(none)

Enrollment

Location

17.6

Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intracranial Aneurysms	Device: PC 400

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

67 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

May 1, 2015

Actual Primary Completion Date :

Oct 19, 2016

Actual Study Completion Date :

Oct 19, 2016

Arms and Interventions

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

Arm

Intervention/Treatment

PC 400

Patients treated with the PC 400 according to the IFU

Device: PC 400

Conventional Embolic Coils

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

Device: PC 400

Outcome Measures

Primary Outcome Measures

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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Overlake Hospital Medical Center	Bellevue	Washington	United States	98004

Sponsors and Collaborators

Penumbra Inc.

Investigators

Principal Investigator: Abhineet Chowdhary, MD, Director of Neuro-Interventional Surgery, Overlake Hospital Medical Center, Bellevue, WA 98004

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Penumbra Inc.

ClinicalTrials.gov Identifier:

NCT02122133

Other Study ID Numbers:

CLP 7495

First Posted:

Apr 24, 2014

Last Update Posted:

Apr 12, 2019

Last Verified:

Apr 1, 2019

Keywords provided by Penumbra Inc.

IC aneurysms, coil embolization, PC 400, radiation exposure,

Additional relevant MeSH terms:

Intracranial Aneurysm

Aneurysm

Study Results

No Results Posted as of Apr 12, 2019