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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

2270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-10

Study Completion Date

2019-06-01

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 .

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Detailed Description

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Conditions

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Cerebral Revascularization Ischemic Cerebrovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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model controlling

an statistical model for periprocedural blood pressure control

Group Type EXPERIMENTAL

model controlling

Intervention Type OTHER

control blood pressure by statistical l model with anticipate lowest peri-procedure risk

conventional controlling

an conventional strategy for periprocedural blood pressure control

Group Type ACTIVE_COMPARATOR

conventional controlling

Intervention Type OTHER

control blood pressure by conventional strategy

Interventions

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model controlling

control blood pressure by statistical l model with anticipate lowest peri-procedure risk

Intervention Type OTHER

conventional controlling

control blood pressure by conventional strategy

Intervention Type OTHER

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;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No