Carotid Artery Stent Implantation in the Treatment of Vulnerable Plaque

NCT ID: NCT05524207

Last Updated: 2022-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-12-30

Brief Summary

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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

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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.

Conditions

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Carotid Artery Plaque Carotid Stenosis Stent Embolisation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Vulnerable plaque group

Patients with preoperative contrast-enhanced intra-plaque contrast agent were classified as vulnerable plaque group

carotid artery stenting

Intervention Type PROCEDURE

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

carotid artery stenting

Intervention Type PROCEDURE

Implantation of stents at the site of carotid artery stenosis for the treatment of carotid plaque with severe stenosis

Interventions

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carotid artery stenting

Implantation of stents at the site of carotid artery stenosis for the treatment of carotid plaque with severe stenosis

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Tsinghua Chang Gung Hospital

OTHER

Sponsor Role lead

Responsible Party

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Keqiang Zhao

Attending Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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sifan yang

Role: STUDY_DIRECTOR

Beijing Tsinghua Chang Gung Hospital

Locations

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Beijing Tsinghua Chang Gung Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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keqiang zhao, M.D.

Role: CONTACT

0086-56119121

weiwei wu, M.D.

Role: CONTACT

0086-56118899

Facility Contacts

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keqiang zhao, M.D.

Role: primary

0086-56118899

Other Identifiers

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20220816

Identifier Type: -

Identifier Source: org_study_id

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