MISTIE III:  A phase III, randomized, open-label, 500-subject clinical trial of minimally invasive surgery plus rt-PA in the treatment of intracerebral hemorrhage.
Aims:
The purpose of this study is to determine the safety and effectiveness of an emergency treatment for intracerebral hemorrhage (spontaneous bleeding in the brain) as compared to current standard of care. The investigational treatment involves a procedure to remove the blood clot in the brain through a small tube, and the use of a drug called rt-PA, to break up the clot and further aid in its removal.  Study participants will be randomly assigned to either the investigational treatment or current standard of care, which does not include removal of the clot
Principal Investigator:
Shakeel Chowdhry, MD
IRB Approval Number:
EH13-028
Funding Source:
Johns Hopkins University/The National Institute of Neurological Disorders and Stroke (NINDS)
Contact:
Please call 847.570.4224 with questions regarding the study
Open to Enrollment:
Yes

SOCRATES – Acute Stroke Or Transient Ischaemic Attack Treated with Aspirin or Ticagrelor and Patient Outcomes Trial
A  Randomised, Double-Blind, Multinational Study to Prevent Major Vascular Events with Ticagrelor Compared to Aspirin (ASA) in Patients with Acute Ischaemic Stroke or TIA
Aims:
To compare the effect of 90-day treatment with ticagrelor (180mg loading dose on Day 1 followed by 90mg twice daily for the remainder of the study) vs aspirin (300mg loading dose on Day 1 followed by 100mg once daily for the remainder of the study) for the prevention of major vascular events (composite of stroke, myocardial infarction and death) in patients with acute ischaemic stroke or TIA when initiated within 24 hours
Principal Investigator:
Rima Dafer, MD, MPH
IRB approval number:
EH13-430
Funding source:
Astra Zeneca
Contact:
Please call 847.503.4322 with questions regarding the study
Open to enrollment:
Projected March 2014

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, MD, MPH
IRB approval number:  EH11-057
Funding source: The National Institute of Neurological Disorders and Stroke (NINDS)
Contact:  Please call 847.503.4322 with questions regarding the study
Open to enrollment:  Yes

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 vessel
Principal Investigator: Hamad Farhat, MD
IRB Approval Number: EH12-355
Funding Source: Manufacturer: Stryker 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.

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