Actively Recruiting
CAS for Stenosis With High-risk Features for CEA
Led by Beijing Tiantan Hospital · Updated on 2026-04-14
212
Participants Needed
16
Research Sites
147 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
The purpose of this prospective, multicenter, single-group target-value study is to evaluate the safety and efficacy of the carotid artery stent system in patients with high-risk features for carotid endarterectomy. This trial is utilizing the carotid artery stent system provided by Shanghai HeartCare Medical Technology Co., Ltd. and will be conducted at approximately 10 interventional neurology centers in China.
CONDITIONS
Official Title
CAS for Stenosis With High-risk Features for CEA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, male or female
- Carotid artery narrowing confirmed by ultrasound or CT angiography and suitable for endovascular treatment
- Stenosis confirmed by angiography: 50% or more if symptomatic or 80% or more if asymptomatic
- Symptomatic defined as clinical events within 6 months prior, including transient ischemic attack, amaurosis fugax, or minor stroke
- Target vessel diameter between 3.0 mm and 9.0 mm
- Voluntary participation with written informed consent
- High-risk features for carotid endarterectomy including comorbidities such as age 75 or older, heart failure NYHA Class III/IV, unstable angina, severe COPD, left ventricular ejection fraction 30% or less, recent myocardial infarction, coronary artery disease with major vessel stenosis, or planned coronary bypass or valve surgery within 31 to 60 days
- Anatomical factors such as lesions at or above second cervical vertebra, history of head and neck surgery or radiotherapy, limited neck mobility, tracheostomy, vocal cord paralysis or laryngectomy, contralateral nerve palsy, restenosis after previous carotid surgery, severe contralateral carotid artery stenosis or occlusion, or severe tandem lesions coverable by a single stent
You will not qualify if you...
- Lesions caused by carotid arteritis
- Lesions at the origin of the common carotid artery
- Lesions with extensive calcification or tortuosity preventing stent delivery
- Asymptomatic complete occlusion or "string sign" lesions
- Lesions near significant acute or subacute thrombus or arteriovenous malformation
- Major surgery within 30 days before or planned within 30 days after the procedure
- Intracranial hemorrhage or progressive stroke within 3 months before procedure
- Extensive hemispheric stroke within 2 weeks before procedure
- Bradycardia (heart rate below 40 bpm) before procedure
- Paroxysmal atrial fibrillation in past 6 months or requiring long-term anticoagulation
- Known or potential thromboembolism sources
- Intracranial aneurysm needing surgery before procedure
- Coagulation or bleeding disorders
- Contraindications to heparin or antiplatelet drugs
- Low platelet count below 100 x 10^9/L
- Allergies to device components or contrast agents
- Severe liver or kidney dysfunction
- Uncontrolled severe high blood pressure
- Pre-procedure modified Rankin Scale score over 3
- Extensive metastatic cancer
- Participation in another drug or device trial
- Female patients who are pregnant, 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
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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
Research Team
J
Jiabao Yang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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