Carotid Artery Stent Implantation in the Treatment of Vulnerable Plaque

Recruiting

• Conditions: Stent Embolisation; Carotid Artery Plaque; Carotid Stenosis
• Interventions: Procedure: carotid artery stenting

• Registration Number: NCT05524207
• Lead Sponsor: Beijing Tsinghua Chang Gung Hospital

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.

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2022-08
• Study First Submitted: 2022-08-30
• Study First Submitted QC: 2022-08-30
• Last Update Submitted: 2022-08-30
• Study First Posted: 2022-09-01
• Last Update Posted: 2022-09-01
• Primary Completion: 2023-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stable plaque group	carotid artery stenting	The patients with no contrast agent enhancement in the plaque showed preoperative contrast-enhanced ultrasound were classified as stable plaque group
Vulnerable plaque group	carotid artery stenting	Patients with preoperative contrast-enhanced intra-plaque contrast agent were classified as vulnerable plaque group

Primary Outcome Measures

Name	Time	Method
Perioperative 30-day stroke rate	30 days	To determine whether there is a new cerebral infarction by postoperative re-examination of brain MRI and preoperative brain MRI

Secondary Outcome Measures

Name	Time	Method
1-year stroke rate after surgery	1 year	Stroke rate in ipsilateral carotid artery blood supply area within 1 year after operation

Trial Locations

Locations (1)

Beijing Tsinghua Chang Gung Hospital; 🇨🇳 Beijing, China