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Sponsors and Collaborators: |
The University of North Carolina, Chapel Hill National Institute of Neurological Disorders and Stroke (NINDS) Washington University School of Medicine University of Iowa |
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Information provided by: | National Institute of Neurological Disorders and Stroke (NINDS) |
ClinicalTrials.gov Identifier: | NCT00029146 |
The purpose of this study is to determine if extracranial-intracranial bypass surgery when added to best medical therapy can reduce the subsequent risk of ipsilateral stroke in high-risk patients with recently symptomatic carotid occlusion and increased cerebral oxygen extraction fraction measured by PET.
Condition | Intervention | Phase |
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Stroke Ischemic Attack, Transient Cerebral Infarction |
Procedure: extracranial-intracranial bypass surgery Other: best medical therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Carotid Occlusion Surgery Study |
Estimated Enrollment: | 1400 |
Study Start Date: | July 2002 |
Estimated Study Completion Date: | November 2014 |
Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Surgical group: Experimental
Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
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Procedure: extracranial-intracranial bypass surgery
Surgical anastomosis of a superficial temporal artery branch to a middle cerebral artery branch through a small craniectomy
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Non-surgical group: Active Comparator
Receives best current practice medical therapy
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Other: best medical therapy
best current practice medical therapy
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The overall purpose of this research is to determine if a surgical operation called "Extracranial-Intracranial Bypass" can reduce the chance of a subsequent stroke in someone who has complete blockage in one main artery in the neck (the carotid artery) that supplies blood to the brain and has already suffered a small stroke. This surgery involves taking an artery from the scalp outside the skull, making a small hole in the skull and then connecting the scalp artery to a brain artery inside the skull. In this way the blockage of the carotid artery in the neck is bypassed and more blood can flow to the brain. In some people natural bypass arteries develop and the brain is already getting plenty of blood. These people have a low risk of stroke if they take medicine. In other people, no natural bypass arteries develop so less blood flows to their brains. This second group has a much higher risk of stroke while taking medicine, as high as 25-50% within the next two years. It is this second group of people who may benefit from having the bypass operation and who are the candidates for this study.
This bypass surgery is considered experimental because it is not generally performed for this condition and it is unknown whether it leads to a decrease, an increase or no change in the risk of stroke. In order to determine if people fit into this second group of people who may benefit from the bypass operation they need to have a test called a PET scan. The PET scan measures the amount of blood that is getting to the brain and the amount of oxygen that the brain is using. The PET scan uses radioactive oxygen and water and is experimental (not approved by the United States Food and Drug Administration). If the PET scan shows that less blood is getting to the brain, there will be a 50-50 chance (like a coin toss) of receiving the bypass surgery or not. There will then be follow-up visits to the clinic one month later and then every three months for two years to check on the appropriate medical treatment that everyone will receive and to determine who has had a stroke.
The study hypothesis is that extracranial-intracranial bypass surgery when added to best medical therapy can reduce by 40 percent subsequent stroke within two years in participants with recent TIA ('ministroke") or stroke (</= 120 days) due to blockage of the carotid artery and reduced blood flow to the brain measured by PET.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion:
Exclusion:
Contact: Carol Papps, RN | 314-603-8413 | carol@npg.wustl.edu |
United States, Missouri | |
Washington University School of Medicine | Recruiting |
St. Louis, Missouri, United States, 63110 | |
Contact: Mary Catanzaro, RN 314-362-3466 catanzarom@wustl.edu | |
Principal Investigator: Colin Derdeyn, M.D. |
Principal Investigator: | William J. Powers, M.D. | The University of North Carolina, Chapel Hill |
Responsible Party: | University of North Carolina School of Medicine ( William J. Powers, MD, Professor of Neurology ) |
Study ID Numbers: | R01NS42167, R01NS41895, CRC |
Study First Received: | January 8, 2002 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00029146 |
Health Authority: | United States: Food and Drug Administration |
stroke transient ischemic attack (TIA) carotid arteries cerebral infarction stroke |
Ischemic Attack, Transient Necrosis Cerebral Infarction Stroke Vascular Diseases Central Nervous System Diseases |
Brain Ischemia Brain Infarction Ischemia Brain Diseases Infarction Cerebrovascular Disorders |
Pathologic Processes Nervous System Diseases Cardiovascular Diseases |