Ultrasound Evaluation of Carotid Artery Atherosclerotic Plaques and Recanalization

NCT03786666 | Completed

• 1 other identifier: VUS-CAS
• Study Type: observational
• Target: 1,213
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this multiple-center study are: 1) To establish the ultrasound criteria for evaluating vulnerable plaques by comparing the plaque echo characteristics before CEA (carotid artery endarterectomy) and plaque specimen after CEA. 2\) To establish the carotid artery recanalization strategies based on the evaluation results of carotid artery and intracranial artery by color doppler flow imaging and TCCS/TCD (transcranial color coded sonography/transcranial doppler). 3\) To compare the success rate and the incidence of restenosis between CEA and carotid artery stenting.

Conditions

Stroke

Keywords

Stroke; Ischemia; Carotid artery Stenosis; CEA; Stenting; Ultrasound; Vulnerable plaque

Outcome Measures

Primary Outcomes (1)

• The rate of combination endpoints events including death, cerebral hemorrhage , newly cerebral infarction, hyperperfusion syndrome,and residual sternosis≥50%.

  The rate of combination endpoints events, including death, cerebral hemorrhage , newly cerebral infarction, hyperperfusion syndrome, and residual sternosis≥50%

  within 30-day after recanalization.

Secondary Outcomes (1)

• the rate of re-current cerebral artery events and the occurence of restenosis

  during the at least 1 year follow-up period

Interventions

Carotid artery recanalization CEA or carotid artery stenting PROCEDURE

Carotid artery recanalization CEA or carotid artery stenting

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with carotid artery moderate (50-69%), severe (70-99%) stenosis or occlusion, who needs recanalization by CEA or stenting.

You may qualify if:

• \) Patients with carotid artery moderate (50-69%, with symptoms), severe (70-99%, with or without symptoms) stenosis or occlusion diagnosed by CDFI and confirmed by CTA or DSA.
• \) Patient has the indications for carotid artery stenting or CEA according to the guidelines published by the Stroke Prevention Engineering Committee, the National Health Commission of China.
• \) Patient with complete imaging evaluation and can be followed up to at least 1 year.

You may not qualify if:

• \- 1) Patients with non-atherosclerotic carotid artery stenosis or occlusion, such as dissection, aneurysm, arteritis, cardiac embolism and et al.
• \) Patients with cerebral hemorrhage. 3) Pregnant

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead
• The First Affiliated Hospital of Soochow University: collaborator
• The First Hospital of Jilin University: collaborator
• The First Affiliated Hospital of Shanxi Medical University: collaborator
• The Second People's Hospital of Liaocheng: collaborator
• Liaocheng Brains Hospital: collaborator
• Lanzhou University Second Hospital: collaborator
• First Hospital of China Medical University: collaborator
• Dalian Municipal Central Hospital: collaborator
• Peking University Third Hospital: collaborator
• The Affiliated Hospital of Inner Mongolia Medical University: collaborator
• Henan Provincial People's Hospital: collaborator
• Shengli Oilfield Hospital: collaborator
• Zhengzhou First People's Hospital: collaborator
• Weihai Municipal Hospital: collaborator

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Carotid artery plaques removed by CEA.

MeSH Terms

Conditions

Stroke; Ischemia; Carotid Stenosis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carotid Artery Diseases; Arterial Occlusive Diseases

Study Officials

• Yang Hua, MD

  No.45 Changchun Road, Beijing,100053, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: December 26, 2018
• Study Start: May 16, 2019
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: March 17, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)