Early Warning and Optimization Strategy in Carotid Endarterectomy

Active, not recruiting

Phase 4 Results N/A

Trial Description

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 .

Detailed 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.

Conditions

Interventions

  • CEA and TCD monitoring Procedure
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: CEA and TCD monitoring
    Description: 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.

Trial Design

  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Mortality 30 days Yes
Secondary cardiac and neurological morbidity (TIA and CVA) 12 months Yes
Secondary brain hyperperfusion 12 months Yes
Secondary long term recurrence 12 months Yes

Sponsors