Status:

UNKNOWN

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

Lead Sponsor:

Xuanwu Hospital, Beijing

Collaborating Sponsors:

Beijing Tiantan Hospital

Peking University Third Hospital

Conditions:

Cerebral Revascularization

Ischemic Cerebrovascular Disease

Eligibility:

All Genders

18+ years

Phase:

NA

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 establ...

Eligibility Criteria

Inclusion

  • 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

  • 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;

Key Trial Info

Start Date :

April 10 2017

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2019

Estimated Enrollment :

2270 Patients enrolled

Trial Details

Trial ID

NCT03256513

Start Date

April 10 2017

End Date

June 1 2019

Last Update

August 22 2017

Active Locations (1)

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1

Department of neurosurgery, Xuanwu hospital

Beijing, China, 100053