Carotid Artery Stent Implantation in the Treatment of Vulnerable Plaque (CASTLE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Carotid Artery Plaque; Carotid Stenosis; Stent Embolisation
• Intervention / Treatment: Procedure: carotid artery stenting

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: keqiang zhao, M.D.; Phone Number: 0086-56119121; Email: zkqiang@139.com
• Study Contact Backup: Name: weiwei wu, M.D.; Phone Number: 0086-56118899

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Tsinghua Chang Gung Hospital
    • Contact: keqiang zhao, M.D.; Phone Number: 0086-56118899; Email: zkqiang@139.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

the patients suffering from carotid artery stenosis

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Vulnerable plaque group; Patients with preoperative contrast-enhanced intra-plaque contrast agent were classified as vulnerable plaque group	Procedure: carotid artery stenting; Implantation of stents at the site of carotid artery stenosis for the treatment of carotid plaque with severe stenosis
Stable plaque group; The patients with no contrast agent enhancement in the plaque showed preoperative contrast-enhanced ultrasound were classified as stable plaque group	Procedure: carotid artery stenting; Implantation of stents at the site of carotid artery stenosis for the treatment of carotid plaque with severe stenosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
1-year stroke rate after surgery	Stroke rate in ipsilateral carotid artery blood supply area within 1 year after operation	1 year

Collaborators and Investigators

• Sponsor: Beijing Tsinghua Chang Gung Hospital
• Investigators: Study Director: sifan yang, Beijing Tsinghua Chang Gung Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): December 30, 2023
• Study Completion (Anticipated): December 30, 2024

Study Registration Dates

• First Submitted: August 30, 2022
• First Submitted That Met QC Criteria: August 30, 2022
• First Posted (Actual): September 1, 2022

Study Record Updates

• Last Update Posted (Actual): September 1, 2022
• Last Update Submitted That Met QC Criteria: August 30, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: carotid stenting; carotid artery stenosis; vulnerable plague
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Carotid Artery Diseases; Carotid Stenosis
• Other Study ID Numbers: 20220816

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No