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

Capital Medical University

Status: Unknown

Conditions: Cerebral Revascularization; Ischemic Cerebrovascular Disease

Treatments: Other: model controlling; Other: conventional controlling

Study type: Interventional

Funder types: Other

Identifiers

NCT03256513

D161100003816002

Details and patient eligibility

About

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 .

Enrollment: 2,270 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,270 participants in 2 patient groups

model controlling

Experimental group

Description:

an statistical model for periprocedural blood pressure control

Treatment:

Other: model controlling

conventional controlling

Active Comparator group

Description:

an conventional strategy for periprocedural blood pressure control

Treatment:

Other: conventional controlling