Carotid Occlusion Surgery Study - Full Text View

Sponsor:	University of North Carolina, Chapel Hill
Collaborators:	National Institute of Neurological Disorders and Stroke (NINDS) Washington University School of Medicine University of Iowa
Information provided by:	University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT00029146

Purpose

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
Stroke Ischemic Attack, Transient Cerebral Infarction	Procedure: extracranial-intracranial bypass surgery Other: best medical therapy	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Carotid Occlusion Surgery Study

Resource links provided by NLM:

MedlinePlus related topics: Transient Ischemic Attack

U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:

Surgical group:combination of the occurrence of ipsilateral ischemic stroke within 2 yrs of randomization and of all stroke & death from surgery through 30 days post operation [ Time Frame: within 2 yrs of randomization ] [ Designated as safety issue: No ]
Non-surgical group: combination of the occurrence of ipsilateral ischemic stroke within 2 yrs of randomization and of all stroke & death from randomization through 30 days post randomization [ Time Frame: within 2 yrs of randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

all stroke, disabling stroke, fatal stroke, death, Rankin Scale, NIHSS, modified Barthel Index and SS-QOL Quality of Life assessment [ Time Frame: within two years after randomization ] [ Designated as safety issue: No ]

Enrollment:	700
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
Experimental: Surgical group Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy	Procedure: extracranial-intracranial bypass surgery Surgical anastomosis of a superficial temporal artery branch to a middle cerebral artery branch through a small craniectomy Other Names: EC-IC Arterial Bypass STA-MCA Bypass
Active Comparator: Non-surgical group Receives best current practice medical therapy	Other: best medical therapy best current practice medical therapy

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Vascular imaging demonstrating occlusion of one or both internal carotid arteries.
Transient ischemic attack (TIA) or ischemic stroke in the hemispheric carotid territory of one 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).
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 Criteria:

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.
Acute, progressing or unstable neurological deficit. Neurological deficit must be stable for 72 hours prior to the performance of PET.
If supplemental arteriography is required, allergy to iodine or x-ray contrast media, serum creatinine > 3.0 mg/dl or other contraindication to arteriography.
If aspirin is to be used as antithrombotic therapy in the perioperative period, those with allergy or contraindication to aspirin are ineligible.
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.
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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00029146

Locations

United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110

Sponsors and Collaborators

University of North Carolina, Chapel Hill

National Institute of Neurological Disorders and Stroke (NINDS)

Washington University School of Medicine

University of Iowa

Investigators

Principal Investigator:

William J. Powers, M.D.

University of North Carolina, Chapel Hill

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Full list of actively recruiting sites This link exits the ClinicalTrials.gov site

Publications:

Grubb RL Jr, Derdeyn CP, Fritsch SM, Carpenter DA, Yundt KD, Videen TO, Spitznagel EL, Powers WJ. Importance of hemodynamic factors in the prognosis of symptomatic carotid occlusion. JAMA. 1998 Sep 23-30;280(12):1055-60.

Derdeyn CP, Gage BF, Grubb RL Jr, Powers WJ. Cost-effectiveness analysis of therapy for symptomatic carotid occlusion: PET screening before selective extracranial-to-intracranial bypass versus medical treatment. J Nucl Med. 2000 May;41(5):800-7.

Adams HP Jr, Powers WJ, Grubb RL Jr, Clarke WR, Woolson RF. Preview of a new trial of extracranial-to-intracranial arterial anastomosis: the carotid occlusion surgery study. Neurosurg Clin N Am. 2001 Jul;12(3):613-24, ix-x.

Grubb RL Jr, Powers WJ, Derdeyn CP, Adams HP Jr, Clarke WR. The Carotid Occlusion Surgery Study. Neurosurg Focus. 2003 Mar 15;14(3):e9.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Powers WJ, Clarke WR, Grubb RL Jr, Videen TO, Adams HP Jr, Derdeyn CP; COSS Investigators. Extracranial-intracranial bypass surgery for stroke prevention in hemodynamic cerebral ischemia: the Carotid Occlusion Surgery Study randomized trial. JAMA. 2011 Nov 9;306(18):1983-92.

Responsible Party:	William J. Powers, MD, Professor of Neurology, University of North Carolina School of Medicine
ClinicalTrials.gov Identifier:	NCT00029146 History of Changes
Other Study ID Numbers:	R01NS042167, R01NS041895
Study First Received:	January 8, 2002
Last Updated:	August 6, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of North Carolina, Chapel Hill:

stroke
transient ischemic attack (TIA)
carotid arteries
cerebral infarction

Additional relevant MeSH terms:

Cerebral Infarction
Stroke
Ischemic Attack, Transient
Infarction
Ischemia
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders

Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on February 12, 2012