Research Clinical Trials
Research at TSI
The Texas Stroke Institute is committed to cutting-edge research that will help advance our understanding of the prevention, diagnosis, and treatment of brain-attacks. The Texas Stroke Institute is involved with clinical trials and registries, as well as translational research.
The Texas Stroke Institute has a dedicated team of physicians, nurses, clinical trial coordinators, and regulatory specialists to help assist with the initiation, conduct and completion of research projects and clinical trials.
IRB Process at TSI
Research projects of the Texas Stroke Institute are reviewed by the Institutional Review Boards (IRB) at three hospitals namely the Medical City of Dallas Hospital, The Medical Center of Plano, and Plaza Medical Center.
The Medical City Dallas Hospital IRB also serves as the centralized IRB (North Texas Institutional Review Board) responsible for research projects at the rest of the HCA North Texas Division hospitals including Denton Regional Medical Center, Las Colinas Medical Center, Lewisville Medical Center, Medical Center of Arlington, Medical Center of McKinney, and the Medical City Dallas ambulatory Surgery Center. For more information, click here.
IRB submission dates: 2 weeks prior to IRB meeting
IRB meeting: monthly
Stroke Clinical Trials
The Functional Improvement and Recovery after STROKE Trial: The FIRST Trial is a Prospective, single-arm, multi-center study to determine the natural history of acute ischemic stroke from large vessel thrombo-embolism in the brain. Patient’s who present within 8 hours from stroke symptom onset with a NIH Stroke Scale (NIHSS) score >10 and who are ineligible for IV-rtpa or endovascular therapy will be considered for the study. The functional outcomes as defined by the modified Rankin Scale (mRS) of all enrolled patients will be followed for 90 days after the index event. The study has been reviewed by the centralized North Texas Division IRB at the Medical City of Dallas Hospital as well as IRB at The Medical Center of Plano.
Principal Investigator: Vallabh Janardhan, MD
Sponsor: Penumbra Inc., Alameda, CA
Interventional Neurology Clinical Trials
Neuroform3 Microdelivery Stent System (Boston Scientific Inc., Fremont, CA) is FDA-approved under the humanitarian device exemption clause for the treatment of wide neck brain aneurysms. The device has been approved for use through the The Medical Center of Plano IRB and has been reviewed through the Medical City of Dallas Hospital IRB.
Principal Investigator: Vallabh Janardhan, MD
Sponsor: Boston Scientific Inc., Fremont, CA
Wingspan Stent System with Gateway PTA Balloon Catheter (Boston Scientific Inc., Fremont, CA) is an FDA-approved device under the humanitarian device exemption clause for the treatment of intracranial stenosis refractory to medical therapy. The device has been approved for use through the Medical City Dallas Hospital IRB and The Medical Center of Plano IRB.
Principal Investigator: Vallabh Janardhan, MD
Sponsor: Boston Scientific Inc., Fremont, CA
SAPPHIRE WORLDWIDE (SAPPHIRE WW) is a landmark observational registry designed to characterize the outcomes of carotid artery stenting with embolic protection in high-surgical-risk patients. Carotid stenting with embolic protection is performed using FDA-approved devices (Cordis Corporation Inc., Miami, FL). The registry is being submitted to The Medical Center of Plano IRB for review.
Co-Investigator: Vallabh Janardhan, MD
Sponsor: Cordis Corporation Inc., Miami, FL
The Texas Stroke Institute is dedicated to the compassionate, multi-disciplinary and quality care for patients who suffer stroke and disorders of the head, neck, brain and spine. We offer patients cutting-edge treatment options for neurovascular disorders, including minimally invasive catheter-based therapies for adults and children. We encourage academic and research excellence, community awareness and prevention education.