Carotid Artery Stent Implantation in the Treatment of Vulnerable Plaque

Carotid Stenosis Clinical Trial

— CASTLE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05524207
• Other study ID #: 20220816
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: August 2022
• Source: Beijing Tsinghua Chang Gung Hospital
• Contact: keqiang zhao, M.D.
• Phone: 0086-56119121
• Email: zkqiang[@]139.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Carotid Artery Plaque
• Carotid Stenosis
• Stent Embolisation

Intervention

Procedure:
• carotid artery stenting
Implantation of stents at the site of carotid artery stenosis for the treatment of carotid plaque with severe stenosis

Locations

Country	Name	City	State
China	Beijing Tsinghua Chang Gung Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tsinghua Chang Gung Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative 30-day stroke rate	To determine whether there is a new cerebral infarction by postoperative re-examination of brain MRI and preoperative brain MRI	30 days
Secondary	1-year stroke rate after surgery	Stroke rate in ipsilateral carotid artery blood supply area within 1 year after operation	1 year