This trial is active, not recruiting.

Conditions carotid stenosis, carotid artery diseases, stroke, vascular diseases
Treatment cea and tcd monitoring
Phase phase 4
Sponsor Peking Union Medical College Hospital
Start date January 2010
End date December 2012
Trial size 150 participants
Trial identifier NCT01210937, pumch-CAS


Carotid endarterectomy has been proven effective in prevention of cerebral vascular events in patients with severe carotid artery stenosis (symptomatic,>50%;asymptomatic,60%). But during the surgery, when the carotid artery is clipping, the patient will have the chance to have hypoperfusion or stroke. Our study is designed to determine how to use TCD to reduce the risk of death and nonfatal stroke in patients .

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
CEA involves a neck incision and physical removal of the plaque from the inside of the artery.During the surgery, the patient will be monitored by TCD.
cea and tcd monitoring
All patients will receive carotid endarterectomy. During the surgery, all of them will be monitored by TCD. Record the blood flow velocity and blood pressure on specified time.

Primary Outcomes

time frame: 30 days

Secondary Outcomes

cardiac and neurological morbidity (TIA and CVA)
time frame: 12 months
brain hyperperfusion
time frame: 12 months
long term recurrence
time frame: 12 months

Eligibility Criteria

Female participants from 40 months up to 80 years old.

Inclusion Criteria: - Carotid artery stenosis detectable by duplex ultrasound, and no previous procedure done on it, which might well need procedural treatment now with CEA or CAS. - Already started any appropriate medical treatment (eg, statin, aspirin etc), and already recovered from any necessary coronary procedures (eg, CABG) - Patient seems fit and willing for follow-up in person (at 1 month) and by annual letter (for at least 5 years) - Some type of angiography (eg, MRA or CTA) has already been done that has shown that CEA . Exclusion Criteria: - Small likelihood of worthwhile benefit (eg, very low risk of stroke because stenosis is very minor, or major co-morbidity or life-threatening disease, such as advanced cancer)

Additional Information

Official title Early Warning and Optimization Strategy in Carotid Endarterectomy
Principal investigator Liu Bao, doctor
Description AHA guidelines recommend carotid endarterectomy (CEA) for severe carotid stenosis. But during CEA, there is little chance that the patient suffer from severe hypoperfusion or stroke. So we use TCD to monitor the blood flow of brain in the surgery and keep the blood pressure stable. The sudy is designed to find out whether the index which we found in previous work is more sensitive to show the blood flow of middle cerebral artery.
Trial information was received from ClinicalTrials.gov and was last updated in December 2012.
Information provided to ClinicalTrials.gov by Peking Union Medical College Hospital.