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Clinical Trials/NCT05524207
NCT05524207
Recruiting
Not Applicable

A Controlled Clinical Study of Carotid Artery Stent Implantation in the Treatment of Vulnerable Plaque

Beijing Tsinghua Chang Gung Hospital1 site in 1 country100 target enrollmentJanuary 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Carotid Artery Plaque
Sponsor
Beijing Tsinghua Chang Gung Hospital
Enrollment
100
Locations
1
Primary Endpoint
Perioperative 30-day stroke rate
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

To investigate the efficacy and safety of carotid stenting for vulnerable carotid plaques. All patients with carotid artery stenosis underwent carotid arterial contrast-enhanced ultrasonography before operation. According to the examination results, they were divided into two groups: vulnerable plaque group and stable plaque group. The incidence of perioperative stroke events in the two groups was compared. The incidence of stroke events in the two groups within 1 year was compared.

Detailed Description

1. To enroll 100 cases of patients suffering from carotid artery stenosis。the investigators perform contrast enhanced ultrasound on patients for identifying the vulnerable plagues 2. The investigators divide patients into the stable group and the vulnerable group based on the results of CEUS inspection. 3. All patients undergo carotid stent. To analysis the incidence of postoperative complications such as stroke and mortality within 30 days and to compare the differences between the two groups.

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
December 30, 2024
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Keqiang Zhao

Attending Doctor

Beijing Tsinghua Chang Gung Hospital

Eligibility Criteria

Inclusion Criteria

  • The patients with ischemic symptom whose carotid stenosis were more than 50%
  • The patients without ischemic symptom whose carotid stenosis were more than 70%

Exclusion Criteria

  • • Confirmed with severe intracranial vascular lesions
  • Suffering from the large area cerebral infarction or critical stroke sequela
  • Restenosis after CEA or CAS
  • Suffering from severe coronary heart disease, respiratory failure,the hypertension difficult to controled
  • Patients with malignant tumor or expected life \< 2 years

Outcomes

Primary Outcomes

Perioperative 30-day stroke rate

Time Frame: 30 days

To determine whether there is a new cerebral infarction by postoperative re-examination of brain MRI and preoperative brain MRI

Secondary Outcomes

  • 1-year stroke rate after surgery(1 year)

Study Sites (1)

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