Carotid Endarterectomy and Stenting in a Chinese Population: Safety Outcome of the Revascularization of Extracranial Carotid Artery Stenosis Trial.
Bin Yang, Yan Ma, Tao Wang...
https://pubmed.ncbi.nlm.nih.gov/32686047Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID07370246
Evaluating the Safety and Efficacy of the Carotid Artery Stenting System for Stenosis With High-risk Features for CEA: a Prospective, Multicenter, Single-group Target-value Study in China
Led by Beijing Tiantan Hospital · Updated on 2026-04-14
212
Participants Needed
16
Research Sites
52 weeks
Total Duration
On this page
Sponsors
B
Beijing Tiantan Hospital
Lead Sponsor
S
Shanghai HeartCare Medical Technology Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a carotid artery stent system in patients who have carotid artery stenosis with high-risk features for carotid endarterectomy. This prospective, multicenter study is conducted at about 10 interventional neurology centers in China and focuses on patients considered suitable for endovascular treatment due to significant artery narrowing confirmed by imaging and clinical criteria. Participants will receive the carotid artery stent system, a self-expanding stent made from nitinol provided by Shanghai HeartCare Medical Technology Co., Ltd. This device is delivered using a specialized system designed for placement in the narrowed segment of the carotid artery. The study follows patients through the procedure and monitors them closely over time, including up to one year after treatment. During the study, patients will undergo evaluations for stroke, myocardial infarction, or death within 30 days after the procedure, as well as monitoring for ischemic stroke in the treated artery territory up to one year post-procedure. Additional assessments include rates of in-stent restenosis, procedure and implantation success rates, and any need for further revascularization. Safety and efficacy data are collected through imaging, clinical follow-up, and other tests to assess outcomes and adverse events throughout the one-year observation period.
CONDITIONS
Brief Title
CAS for Stenosis With High-risk Features for CEA
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, male or female
- Confirmed carotid artery stenosis suitable for endovascular treatment via ultrasound or CT angiography
- Stenosis of 50% or more if symptomatic, or 80% or more if asymptomatic, confirmed by angiography
- Symptomatic defined by events like transient ischemic attack or minor stroke within 6 months prior to procedure
- Target vessel diameter between 3.0 mm and 9.0 mm
- Voluntary participation with written informed consent
- Presence of high-risk features for carotid endarterectomy including comorbidities such as age 75 or older, heart failure NYHA Class III/IV, unstable angina, severe COPD, low ejection fraction, recent myocardial infarction, severe coronary artery disease, or planned heart surgery
- Anatomical factors like lesions above C2 vertebra, previous head and neck surgery or radiotherapy, limited cervical spine mobility, tracheostomy, vocal cord paralysis, contralateral nerve palsy, restenosis after prior endarterectomy, severe contralateral carotid artery disease, or severe tandem lesions
You will not qualify if you...
- Target lesions caused by carotid arteritis
- Lesions at origin of common carotid artery
- Lesions with extensive calcification or tortuosity preventing stent delivery
- Complete occlusion or "string sign" lesions
- Lesions near significant thrombus or arteriovenous malformation
- Major surgery within 30 days before or planned within 30 days after procedure
- Intracranial hemorrhage or progressive stroke within 3 months prior
- Extensive hemispheric stroke within 2 weeks prior
- Bradycardia (heart rate below 40 bpm) before procedure
- Paroxysmal atrial fibrillation in past 6 months or requiring long-term anticoagulation
- Known sources of thromboembolism
- Intracranial aneurysm requiring surgery not treatable before procedure
- Known coagulation or bleeding disorders
- Contraindications to heparin or antiplatelet agents
- Platelet count below 100 x 10^9/L
- Allergies to stent components or contrast agents
- Severe liver or kidney disease
- Uncontrolled severe hypertension
- Pre-procedure mRS score over 3
- Extensive metastatic cancer
- Concurrent enrollment in other drug or device trials
- Pregnancy, breastfeeding, or planning pregnancy within 1 year
- Lesions inaccessible by endovascular approach
- Expected survival less than 12 months
- Other investigator-determined unsuitable conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Procedure day
Participants receive the carotid artery stent system device during a procedure to treat carotid artery stenosis with high-risk features for carotid endarterectomy.
1 procedure visit (in-person)
Post-operative Follow-up
Duration - Up to 12 months after the procedure
Participants are monitored for safety and efficacy outcomes including stroke, myocardial infarction, death, and in-stent restenosis over a one-year period after the procedure.
Follow-up visits at 30 days, 6 months, and 12 months after the procedure
Trial Site Locations
Total: 16 locations
1
Beijing Tiantan Hospital, Affiliated to Capital Medical University
Beijing, Beijing Municipality, China, 100070
Actively Recruiting
2
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, China
Actively Recruiting
3
The Second Nanning People's Hospital
Nanning, Guangxi, China
Actively Recruiting
4
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Actively Recruiting
5
Hebei General Hospital
Shijiazhuang, Hebei, China
Actively Recruiting
6
Xingtai Central Hospital
Xingtai, Hebei, China
Actively Recruiting
7
Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
8
Inner Mongolia Autonomous Region People's Hospital
Hohhot, Inner Mongolia, China
Actively Recruiting
9
Jiu Jiang No.1 People's Hospital
Jiujiang, Jiangxi, China
Actively Recruiting
10
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
Actively Recruiting
11
Jining First People's Hospital
Jining, Shandong, China
Actively Recruiting
12
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Actively Recruiting
13
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
14
Lishui Central Hospital
Lishui, Zhejiang, China
Actively Recruiting
15
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
Actively Recruiting
16
The Taizhou First People's Hospital
Taizhou, Zhejiang, China
Actively Recruiting
Loading map...
Research Team
J
Jiabao Yang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Outcomes of 1000 Carotid Wallstent Implantations: Single-Center Experience.
Sonia Ronchey, Barbara Praquin, Matteo Orrico...
https://pubmed.ncbi.nlm.nih.gov/26802612Carotid artery stenting and patient outcomes: the CABANA surveillance study.
L Nelson Hopkins, Christopher J White, Malcolm T Foster...
https://pubmed.ncbi.nlm.nih.gov/24948033Carotid artery revascularization in high-surgical-risk patients using the Carotid WALLSTENT and FilterWire EX/EZ: 1-year outcomes in the BEACH Pivotal Group.
Sriram S Iyer, Christopher J White, L Nelson Hopkins...
https://pubmed.ncbi.nlm.nih.gov/18222352Carotid stenting with distal protection in high surgical risk patients: the BEACH trial 30 day results.
Christopher J White, Sriram S Iyer, L Nelson Hopkins...
https://pubmed.ncbi.nlm.nih.gov/16548004Editor's Choice - European Society for Vascular Surgery (ESVS) 2023 Clinical Practice Guidelines on the Management of Atherosclerotic Carotid and Vertebral Artery Disease.
Ross Naylor, Barbara Rantner, Stefano Ancetti...
https://pubmed.ncbi.nlm.nih.gov/35598721