Carotid Artery Stent Implantation in the Treatment of Vulnerable Plaque

NCT05524207 | Unknown DMC

• 1 other identifier: 20220816
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Carotid Artery Plaque; Carotid Stenosis; Stent Embolisation

Keywords

carotid artery stenosis; vulnerable plague; carotid stenting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 1-year stroke rate after surgery

  1 year

Study Arms (2)

Vulnerable plaque group

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

Procedure: carotid artery stenting

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

Interventions

carotid artery stenting PROCEDURE

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

Stable plaque group; Vulnerable plaque group

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

the patients suffering from carotid artery stenosis

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

Study Sites (1)

Beijing Tsinghua Chang Gung Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Carotid Stenosis

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• sifan yang

  Beijing Tsinghua Chang Gung Hospital

  STUDY DIRECTOR

Central Study Contacts

keqiang zhao, M.D.

CONTACT

0086-56119121; zkqiang@139.com

weiwei wu, M.D.

CONTACT

0086-56118899

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Doctor

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 1, 2022
• Study Start: January 1, 2022
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2024
• Last Updated: September 1, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)