StrokePhase 3COSSNCT00029146

Carotid Occlusion Surgery Study

A Phase 3 study testing extracranial-intracranial bypass surgery and best medical therapy in people with Stroke and Ischemic Attack, Transient, run by University of North Carolina, Chapel Hill at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

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 positron emission… Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Stroke, Ischemic Attack, Transient, Cerebral Infarction
What is being tested?: extracranial-intracranial bypass surgery and best medical therapy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 700 participants
Where: 1 siteUnited States
Study dates: Jul 2002to Jun 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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Competent to give informed consent.
Legally an adult.
Geographically accessible and reliable for follow-up.

Who cannot join

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.

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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).

Trial locations and contacts

1 site in 1 country.

United States1 site

Washington University School of Medicine
St Louis, Missouri, 63110

Other trials in United States

About this study

Read the 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.

Conditions: Stroke, Ischemic Attack, Transient, Cerebral Infarction
Being tested: extracranial-intracranial bypass surgery, best medical therapy
Keywords: stroke, transient ischemic attack (TIA), carotid arteries, cerebral infarction
Medical subject headings: Stroke, Ischemic Attack, Transient, Cerebral Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

extracranial-intracranial bypass surgeryProcedure or surgery
Also called EC-IC Arterial Bypass, STA-MCA Bypass
Surgical anastomosis of a superficial temporal artery branch to a middle cerebral artery branch through a small craniectomy plus best current practice medical therapy
best medical therapyDrug
best current practice medical therapy

Study groups in NCT00029146
Study group	Role	What they receive
Surgical group	Experimental	Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy Receives: Procedure: extracranial-intracranial bypass surgery
Non-surgical group	Active comparator	Receives best current practice medical therapy Receives: Drug: best medical therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Surgical Group:Ipsilateral Ischemic Stroke in 2 Yrs From Randomization and All Stroke & Death Through 30d Post-surgery; Non-surgical Group:Ipsilateral Ischemic Stroke in 2 Yrs From Randomization and All Stroke & Death Through 30d Post-randomization
2 yr Kaplan-Meier estimates of the proportions.Proportions expressed as percentages for reporting purposes. Ipsilateral ischemic stroke is defined as the clinical diagnosis of a focal neurological deficit due to cerebral ischemia clinically localizable within the internal carotid artery territory distally to the symptomatic occluded internal carotid artery that lasts for more than 24 hours. All stroke is defined as the clinical diagnosis of a focal deficit due to ischemia or hemorrhage clinically localizable to the brain that lasts for more than 24 hours. Death is of any cause.
Measured: within 2 yrs of randomization

Secondary outcomes (9)

All Stroke
2 yr Kaplan-Meier estimates of the proportions. All stroke is defined as the clinical diagnosis of a focal deficit due to ischemia or hemorrhage clinically localizable to the brain that lasts for more than 24 hours
Measured: within 2 yrs of randomization
Disabling Stroke
2 yr Kaplan-Meier estimates of the proportions. Disabling stroke is defined as a modified Barthel Index of <12/20 at the first scheduled return visit more than 3 months after the stroke occurred
Measured: within two years after randomization
Fatal Stroke
2 yr Kaplan-Meier estimates of the proportions. Fatal stroke is a stroke that in the investigator's opinion led directly to the participants death within 30 days of occurrence
Measured: within 2 years after randomization
Death
2 yr Kaplan-Meier estimates of the proportions. Death of any cause
Measured: within 2 years after randomization
Modified Rankin 0-1
Proportion with modified Rankin score, dichotomized 0 or 1 vs 2-6.The modifed Rankin (0-6) describes the degree of functional disability. A lower score indicates less functional disability.
Measured: at 2 years after randomization or end of trial. Worst case imputed for death and missing values
Modified Rankin 0-2
Proportion with Modified Rankin score at 2 yrs, dichotomized 0-2 vs 3-6. The modifed Rankin (0-6) describes the degree of functional disability. A lower score indicates less functional disability.
Measured: at 2 years after randomization or end of trial. Worst case imputed for death and missing values
Modified Barthel Index 19-20
Modified Barthel Index dichotomized 19-20 vs <= 18. The modifed Barthel Index(0-20) describes the degree of independence in day-to-day self-care activities. A higher score indicates greater independence.
Measured: at 2 years after randomization or end of trial. Worst case imputed for death and missing values
Summary SS-QOL Score
Summary Stroke Specific Quality of Life score (1-4) askes how self-reported overall quality of life compares with with that before stroke. A higher score indicates is better.
Measured: at 2 years after randomization or end of trial. Worst case imputed for death and missing values
Ipsilateral Ischemic Stroke in 2 Yrs From Randomization and All Stroke & Death Through 30d Post-surgery; Non-surgical Group:Ipsilateral Ischemic Stroke in 2 Yrs From Randomization and All Stroke & Death Through 30d Post-randomization
2 yr Kaplan-Meier estimates of the proportions.Proportions expressed as percentages for reporting purposes. Ipsilateral ischemic stroke is defined as the clinical diagnosis of a focal neurological deficit due to cerebral ischemia clinically localizable within the internal carotid artery territory distally to the symptomatic occluded internal carotid artery that lasts for more than 24 hours. All stroke is defined as the clinical diagnosis of a focal deficit due to ischemia or hemorrhage clinically localizable to the brain that lasts for more than 24 hours. Death is of any cause.
Measured: within 2 years of randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2002Jun 2010

First posted9 Jan 2002 (estimated)
Study startJul 2002
Primary completionJun 2010
Study completionJun 2010

Why it stopped: Pre-specified futility boundary was reached.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 700 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00029146
Sponsor's protocol ID: R01NS042167
Other IDs: R01NS041895
Acronym: COSS
Status last verified: Mar 2012
First submitted: 8 Jan 2002
Last updated: 27 Mar 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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. doi: 10.1001/jama.280.12.1055.
PubMed 9757852
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.
PubMed 10809195
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.
PubMed 11390318
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. doi: 10.3171/foc.2003.14.3.10.
PubMed 15709726
Grubb RL Jr, Powers WJ, Clarke WR, Videen TO, Adams HP Jr, Derdeyn CP; Carotid Occlusion Surgery Study Investigators. Surgical results of the Carotid Occlusion Surgery Study. J Neurosurg. 2013 Jan;118(1):25-33. doi: 10.3171/2012.9.JNS12551. Epub 2012 Oct 26.
PubMed 23101451
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. doi: 10.1001/jama.2011.1610.
PubMed 22068990

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Carotid Occlusion Surgery Study
ClinicalTrials.gov ID: NCT00029146
Acronym / sponsor ID: COSS / R01NS042167
Conditions: Stroke, Ischemic Attack, Transient, Cerebral Infarction
Keywords: stroke, transient ischemic attack (TIA), carotid arteries, cerebral infarction
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Pre-specified futility boundary was reached.
Enrolment: 700 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS), Washington University School of Medicine, University of Iowa
Study start: Jul 2002
Primary completion: Jun 2010 (actual)
Study completion: Jun 2010 (actual)
First posted: 9 Jan 2002 (estimated)
Results: Posted 26 Mar 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Surgical group	Experimental	Procedure: extracranial-intracranial bypass surgeryAssigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
Non-surgical group	Active comparator	Drug: best medical therapyReceives best current practice medical therapy

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (15 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
extracranial-intracranial bypass surgeryAlso: EC-IC Arterial Bypass, STA-MCA BypassSurgical anastomosis of a superficial temporal artery branch to a middle cerebral artery branch through a small craniectomy plus best current practice medical therapy	Procedure or surgery	Surgical group
best medical therapybest current practice medical therapy	Drug	Non-surgical group

Primary outcome

Surgical Group:Ipsilateral Ischemic Stroke in 2 Yrs From Randomization and All Stroke & Death Through 30d Post-surgery; Non-surgical Group:Ipsilateral Ischemic Stroke in 2 Yrs From Randomization and All Stroke & Death Through 30d Post-randomization
Time frame: within 2 yrs of randomization
2 yr Kaplan-Meier estimates of the proportions.Proportions expressed as percentages for reporting purposes. Ipsilateral ischemic stroke is defined as the clinical diagnosis of a focal neurological deficit due to cerebral ischemia clinically localizable within the internal carotid artery territory distally to the symptomatic occluded internal carotid artery that lasts for more than 24 hours. All stroke is defined as the clinical diagnosis of a focal deficit due to ischemia or hemorrhage clinically localizable to the brain that lasts for more than 24 hours. Death is of any cause.

9 secondary outcomes

All Stroke
Time frame: within 2 yrs of randomization
Disabling Stroke
Time frame: within two years after randomization
Fatal Stroke
Time frame: within 2 years after randomization
Death
Time frame: within 2 years after randomization
Modified Rankin 0-1
Time frame: at 2 years after randomization or end of trial. Worst case imputed for death and missing values
Modified Rankin 0-2
Time frame: at 2 years after randomization or end of trial. Worst case imputed for death and missing values
Modified Barthel Index 19-20
Time frame: at 2 years after randomization or end of trial. Worst case imputed for death and missing values
Summary SS-QOL Score
Time frame: at 2 years after randomization or end of trial. Worst case imputed for death and missing values
Ipsilateral Ischemic Stroke in 2 Yrs From Randomization and All Stroke & Death Through 30d Post-surgery; Non-surgical Group:Ipsilateral Ischemic Stroke in 2 Yrs From Randomization and All Stroke & Death Through 30d Post-randomization
Time frame: within 2 years of randomization

Results and safety

Results posted to the registry on 26 Mar 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Surgical Group	97	95
Non-surgical Group	98	97

Primary outcome: Surgical Group:Ipsilateral Ischemic Stroke in 2 Yrs From Randomization and All Stroke & Death Through 30d Post-surgery; Non-surgical Group:Ipsilateral Ischemic Stroke in 2 Yrs From Randomization and All Stroke & Death Through 30d Post-randomization

Time frame: within 2 yrs of randomization. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Surgical Group n = 97	Non-surgical Group n = 98
Value	21.0 (12.8 to 29.2)	22.7 (13.9 to 31.6)

Surgical Group vs Non-surgical Group: Difference in estimated 2 yr rates: 1.7 (95% CI -10.4 to 13.8), p = 0.78, 2-sided z-statistic

Population analysed: Intention to treat principle.All participants analyzed in the group to which they were originally randomized.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Surgical group: Within 30 days after surgery for 93 operated and within 30 days after randomization for 4 not operated Non-surgical group: Within 30 days after randomization. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Surgical Group	14 of 97 (14.4%)	0 of 0	Not reported
Non-surgical Group	2 of 98 (2%)	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 9757852Grubb 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. doi: 10.1001/jama.280.12.1055.
Background: PubMed 10809195Derdeyn 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.
Background: PubMed 11390318Adams 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.
Background: PubMed 15709726Grubb RL Jr, Powers WJ, Derdeyn CP, Adams HP Jr, Clarke WR. The Carotid Occlusion Surgery Study. Neurosurg Focus. 2003 Mar 15;14(3):e9. doi: 10.3171/foc.2003.14.3.10.
Derived from this study: PubMed 23101451Grubb RL Jr, Powers WJ, Clarke WR, Videen TO, Adams HP Jr, Derdeyn CP; Carotid Occlusion Surgery Study Investigators. Surgical results of the Carotid Occlusion Surgery Study. J Neurosurg. 2013 Jan;118(1):25-33. doi: 10.3171/2012.9.JNS12551. Epub 2012 Oct 26.
Derived from this study: PubMed 22068990Powers 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. doi: 10.1001/jama.2011.1610.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

William J. Powers, M.D. principal investigator

University of North Carolina, Chapel Hill

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Surgical Group:Ipsilateral Ischemic Stroke in 2 Yrs From Randomization and All Stroke & Death Through 30d Post-surgery; Non-surgical Group:Ipsilateral Ischemic Stroke in 2 Yrs From Randomization and All Stroke & Death Through 30d Post-randomization (time frame: within 2 yrs of randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00029146, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2012.