A randomised, double-blind, parallel-group, placebo-controlled phase III study to evaluate the efficacy and safety of Desmoteplase in patients with acute ischemic stroke - DIAS 4
Aims: To evaluate the efficacy of desmoteplase 90 μg/kg versus placebo in terms of favorable outcome at Day 90 in subjects with acute ischemic stroke
Principal Investigator: Rima Dafer, M.D., M.P.H.
IRB approval number: EH11-099
Funding source: Lundbeck
Contact: Please call 847.570.2089 with questions regarding the study
Open to enrollment: Yes
Platelet-Oriented Inhibition in New TIA and minor ischemic stroke (POINT) Trial
Aims: To determine whether clopidogrel 75 mg/day by mouth after a loading dose of 600 mg of clopidogrel is effective in preventing major ischemic vascular events (ischemic stroke, myocardial infarction, and ischemic vascular death) at 90 days when initiated within 12 hours of transient ischemic attack (TIA) or minor ischemic stroke onset in patients receiving aspirin 50-325 mg/day (with a dose of 162 mg daily for 5 days followed by 81 mg daily strongly recommended).
Principal Investigator: Rima Dafer, M.D., M.P.H.
IRB approval number: EH11-057
Funding source: The National Institute of Neurological Disorders and Stroke (NINDS)
Contact: Please call 847.570.2089 with questions regarding the study.
TIA Work-up as Outpatient. Assessment of Clinical Efficacy and Safety (TWOACES)
Aims: To examine the rate of stroke after TIA
Principal Investigator: James Castle, M.D.
IRB Approval Number: EH10-017
Funding Source: None (none needed)
Contact: Please call 847.570.2570 with questions regarding this study
Open to Enrollment: Yes
SAPPHIRE World-Wide Post-Market Trial: Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy
Aims: Carotid artery stenting (CAS) is a minimally invasive interventional procedure for reducing the risk of stroke in patients diagnosed with carotid artery disease (CAD)
Principal Investigator: Thomas Grobelny, M.D.
IRB Approval Number: EH09-477
Funding Source: N/A - Manufacturer: Codman Neurovascular
Contact: please call Michelle Catalano at 847.570.1512 with questions regarding the device.
Open to Enrollment: Enrollment starting in September
Humanitarian Use Device: Wingspan Stent System with Gateway PTA Balloon Catheter
Aims: The Wingspan Stent System with Gateway PTA Balloon Catheter is used to treat intracranial stenosis. Neurovascular stents are devices that can help to reduce the risk of recurrent blockage or of narrowing after an angioplasty procedure
Principal Investigator: Thomas Grobelny, M.D.
IRB Approval Number: EH10-054
Funding Source: N/A - Manufacturer: Boston Scientific
Contact: Please call Michelle Catalano at 847.570.1512 with questions regarding the device.
Open to Enrollment: Yes - patients are being treated with this device
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 effected area and is deployed by inflation of a very small balloon, which widens the occluded vessle.
Principal Investigator: Hamad Farhat, MD
IRB Approval Number: EH12-355
Funding Source: N/A – Manufacturer: Codman Neurovascular
Contact: Please call Robert Frech at 847.570.4224 with questions regarding the device.
Open to Enrollment: Yes - patients are being treated with this device.
Note: Humanitarian Use Devices
Humanitarian Device Exemption Overview
An 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.