CARE: A Prospective Multicenter Case Study to Assess Radiation Exposure in Patients Treated with the Penumbra Coil 400™
Aims: This is a multicenter case review study of patients presenting with intracranial aneurysms who are treated with coil embolization therapy using the Penumbra Coil 400 System (PC 400) or conventional coils. The primary objective of this study is to gather data on the radiation exposure in patients treated with the PC 400 or conventional coils per their respective indications for use. This study does not involve randomization. The devices evaluated in this study are FDA-approved.
Principal Investigator: Shakeel Chowdhry, MD
NorthShore Project Number: EH15-172
Funding Source: Penumbra, Inc.
Contact
: Please call 847.570.4224 with questions regarding the study.
Open to Enrollment: Yes

Humanitarian Use Device: Neuroform Microdelivery Stent System
Aims: The Neuroform Microdelivery Stent System is used with coils for treating wide neck aneurysms in the brain that cannot be treated with open brain surgery.
Principal Investigator: Shakeel Chowdhry, MD
NorthShore Project Number: EH12-352
Funding Source: N/A - Manufacturer: Boston Scientific
Contact: Please call 847.570.4224 with questions regarding the device.
Open to Enrollment: Yes - patients are being treated with this device.
Note: Humanitarian Use Devices

Humanitarian Use Device: Wingspan Stent System with Gateway PTA Balloon Catheter
Aims: This device is used to increase cerebral artery blood flow in patients with intracranial atherosclerotic disease. A stent is placed in the affected area and is deployed by inflation of a very small balloon, which widens the occluded vessel.
Principal Investigator: Shakeel Chowdhry, MD IRB Approval Number: EH12-355
NorthShore Project Number: EH12-352
Funding Source
: N/A - Manufacturer: Boston Scientific
Contact: Please call 847.570.4224 with questions regarding the device.
Open to Enrollment: Yes - patients are being treated with this device.
Note: Humanitarian Use Devices

Humanitarian Use Device: Codman ENTERPRISE Vascular Reconstructive Device and Delivery System
Aims: This device is used for treatment of wide neck aneurysm; a stent is placed across the opening or neck of the aneurysm to secure the placement of coils and to maintain blood flow through the artery in which the stent is placed
Principal Investigator: Shakeel Chowdhry, MD
NorthShore Project Number: EH12-354
Funding Source: N/A – Manufacturer: Codman Neurovascular
Contact: Please call 847.570.4224 with questions regarding the device.
Open to Enrollment: Yes - patients are being treated with this device.


Note: Humanitarian Use Devices

A Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. A device manufacturer`s research and development costs could exceed its market returns for diseases or conditions affecting small patient populations. The HUD provision of the regulation provides an incentive for the development of devices for use in the treatment or diagnosis of diseases affecting these populations. An approved HDE authorizes marketing of the HUD. However, an HUD may only be used in facilities that have established a local institutional review board (IRB) to supervise clinical testing of devices and after an IRB has approved the use of the device to treat or diagnose the specific disease. The labeling for an HUD must state that the device is an humanitarian use device and that, although the device is authorized by Federal Law, the effectiveness of the device for the specific indication has not been demonstrated.