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	Treatment or Intervention	Phase
Stroke Ischemic Attack, Transient	Procedure: extracranial-intracranial bypass surgery	Phase III

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.

Ages Eligible for Study:  18 Years   -   85 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion:

• Vascular imaging demonstrating occlusion of one internal carotid artery.
• Transient ischemic attack (TIA) or ischemic stroke in the hemispheric carotid territory of the occluded carotid artery.
• Most recent qualifying TIA or stroke occurring within 120 days prior to projected performance date of PET.
• Modified Barthel Index > 12/20 (60/100). 6. Language comprehension intact, motor aphasia mild or absent.
• Age 18-85 inclusive.
• Competent to give informed consent.
• Legally an adult.
• Geographically accessible and reliable for follow-up.

Exclusion:

• Non-atherosclerotic carotid vascular disease.
• Blood dyscrasias: Polycythemia vera ,essential thrombocytosis, sickle cell disease (SS or SC).
• Known heart disease likely to cause cerebral ischemia (echocardiography not required). This includes the following conditions ONLY: Prosthetic valve, Infective endocarditis, Left atrial or ventricular thrombus, Sick sinus syndrome, Myxoma, Cardiomyopathy with ejection fraction <25%. This is an all-inclusive list. The following conditions are NOT EXCLUSIONS: Atrial fibrillation, patent foramen ovale, atrial septal aneurysm.
• Other non-atherosclerotic condition likely to cause focal cerebral ischemia.
• Any condition likely to lead to death within 2 years.
• Other neurological disease that would confound follow-up assessment.
• Pregnancy.
• Subsequent cerebrovascular surgery planned which might alter cerebral hemodynamics.
• Any condition which in the participating surgeon's judgment makes the subject an unsuitable surgical candidate.
• Participation in any other experimental treatment trial.
• Participation within the previous 12 months in any experimental study that included exposure to ionizing radiation.
• Remediable medical conditions. Patients with the following conditions can become eligible if the exclusion criterion no longer applies within 120 days of onset of the most recent qualifying event: Uncontrolled diabetes mellitus (FBS > 300 mg%/16.7 mmol/L), Uncontrolled hypertension (systolic BP>180, diastolic BP >110), Unstable angina, Uncontrolled hypotension (diastolic BP < 65).
• Acute, progressing or unstable neurological deficit. Neurological deficit must be stable for 72 hours prior to the performance of PET.
• Allergy to iodine or X-ray contrast media.
• Medical indication for treatment with anticoagulant drugs, ticlopidine, clopidogrel or other antithrombotic medications such that these medications cannot be replaced with aspirin in the perioperative period as deemed necessary by the COSS neurosurgeon if the participant is randomized to surgical treatment.

William J. Powers, M.D.      314-362-3317    wjp@npg.wustl.edu

Missouri
      Washington University School of Medicine, Box 8225, 4525 Scott Avenue, St. Louis,  Missouri,  63110,  United States; Recruiting

Study chairs or principal investigators

William J. Powers, M.D.,  Principal Investigator,  Washington University School of Medicine   

Study ID Numbers:  R01NS42167; R01NS41895
Record last reviewed:  July 2004
Record first received:  January 8, 2002
ClinicalTrials.gov Identifier:  NCT00029146
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-08