Clinical trial NCT03256513: The Safety and Efficacy of Peri-procedure Blood Pressure Management of Revascularization
Official title: The Safety and Efficacy of Peri-procedure Blood Pressure Management of Revascularization for Ischemic Cerebral Vascular Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Revascularization
Ischemic Cerebrovascular Disease
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: Beijing Tiantan Hospital
name: Peking University Third Hospital
name: The 306 Hospital of People's Liberation Army
First posted: 2017-08-22
Enrollment: 2270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 .


Eligibility criteria: 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;

Primary outcomes:
measure: death
timeFrame: 30 days
measure: ischemic stroke
timeFrame: 30 days
measure: cardiovascular events
timeFrame: 30 days
Secondary outcomes:
measure: transient ischemic attack,TIA
timeFrame: 30 days
measure: cerebral hemorrhage
timeFrame: 30 days
measure: hyperperfusion syndrome
timeFrame: 30 days
measure: epilepsy
timeFrame: 30 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of neurosurgery, Xuanwu hospital
Study officials:
affiliation: Department of neurosurgery, Xuanwu hospital
name: Liqun Jiao, MD
role: PRINCIPAL_INVESTIGATOR
References: