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

Penumbra

Status: Terminated

Conditions: Intracranial Aneurysms

Treatments: Device: PC 400

Study type: Observational

Funder types: Industry

Identifiers

NCT02122133

CLP 7495

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: All

Volunteers: No 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.

Trial design

67 participants in 2 patient groups

PC 400

Description:

Patients treated with the PC 400 according to the IFU

Treatment:

Device: PC 400

Conventional Embolic Coils

Description:

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

Treatment:

Device: PC 400