Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00029146
Status:
TERMINATED
Last Update Posted:
2012-03-27
First Post:
2002-01-08
Brief Title:
Carotid Occlusion Surgery Study
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Carotid Occlusion Surgery Study
Status:
TERMINATED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Pre-specified futility boundary was reached
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COSS
Brief 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 tomography PET
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01NS041895 | OTHER_GRANT | NINDS | None |