The Safety and Efficacy of Peri-procedure Blood Pressure Management of Revascularization

Study Overview
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Brief Summary
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Objective: Referring The relation between CEA(Carotid endarterectomy) postoperative blood flow monitoring and blood pressure, and combining patient demographics and preoperative risk factors to establish an applicable individual blood pressure controlling model. By comparing with routine antihypertensive strategies through prospective randomized controlled trials , to provide the best perioperative blood pressure control standards and strategies for each patient ,thus better ensuring the safety and efficacy of CEA .

Official Title
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The Safety and Efficacy of Peri-procedure Blood Pressure Management of Revascularization for Ischemic Cerebral Vascular Disease

Conditions
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Cerebral Revascularization, Ischemic Cerebrovascular Disease

Intervention / Treatment
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* Other: model controlling
* Other: conventional controlling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: symptomatic patient with carotid artery stenosis>=50% or asymptomatic patient with carotid artery stenosis>=70%, according to DSA or CTA; without massive cerebral infarction(infarction area >1/2 territory of middle cerebral artery) confirmed by CT or MRI; informed consent acquired. Exclusion Criteria: lesion beyond range limit of procedure (higher than C2); target vascular complete occlusion or ipsilateral intracranial artery severe stenosis or complete occlusion cannot be revascularized via CEA procedure nonatherosclerotic carotid stenosis, such as vasculitis, dissection, congenital vascular malformation; history of instable angina pectoris, myocardial infarction or congestive heart failure within 6 months unable to accept systematic anesthesia; history of severe injury, surgery or radiotherapy on neck; with comorbid hemorrhagic cerebral disease such as intracranial aneurysm or vascular malformation; with comorbid blood system disease causing refractory coagulation dysfunction or rejection to blood or blood products perfusion; with other comorbidity, expected life < 2 years; severe diabetes mellitus difficult to control, blood sugar >300mg/dl; pregnancy or peri-natal period; intolerance to systematic anesthesia or surgery after adequate preparation. intolerance to peri-procedural drug possible to administrated; not cooperating or rejecting to informed consent;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: model controlling<br>an statistical model for periprocedural blood pressure control | Other: model controlling<br>* control blood pressure by statistical l model with anticipate lowest peri-procedure risk<br>|
| Active Comparator: conventional controlling<br>an conventional strategy for periprocedural blood pressure control | Other: conventional controlling<br>* control blood pressure by conventional strategy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death | all cause death | 30 days | 
| ischemic stroke | Ischemic stroke is defined as an acute episode of neurological events with focal symptoms and signs, with a duration of more than 24h and confirmed by imaging. | 30 days | 
| cardiovascular events | Cardiovascular events were defined as: ECG presentation clearly different from preoperative myocardial ischemia, myocardial infarction, arrhythmia and cardiovascular death. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| transient ischemic attack,TIA | transient ischemic attack, TIA is defined as: Patients with new onset of neurological symptoms and / or signs, duration < 24 hours, MRI diffusion weighted imaging (DWI) did not find new infarcts. If MRI DWI showed new lesion, ischemic stroke was defined. | 30 days | 
| cerebral hemorrhage | cerebral hemorrhage including intracerebral hemorrhage, epidural or subdural hemorrhage, subarachnoid hemorrhage. | 30 days | 
| hyperperfusion syndrome | Hyperfusion Syndrome is defined as : 30 days after operation, new onset headache, vomiting, mental symptoms, macular edema, focal seizures, neurological dysfunction, or imaging brain edema, visible bleeding, and exception of new ischemic cerebral infarction or other causes. | 30 days | 
| epilepsy | epilepsy is defined as focal onset, with or without evolution to a bilateral tonic-clonic seizure, confirmed by EEG findings including interictal epileptiform discharges (IEDs), lateralized periodic discharges (LPDs; previously known as periodic lateralized epileptiform discharges [PLEDs]), and generalized periodic discharges (GPDs) | 30 days |