What is this study trying to find out about carotid artery stenosis?

This study is evaluating the safety and effectiveness of a carotid artery stent system in patients with high-risk features for carotid endarterectomy. Researchers want to understand how well the stent works to treat artery narrowing and to monitor risks like stroke or death after the procedure. The study is led by Beijing Tiantan Hospital and conducted at multiple centers in China.

Who may be eligible for this carotid artery stenosis clinical trial?

Adults aged 18 years or older with confirmed carotid artery stenosis suitable for endovascular treatment may be eligible. Both men and women can participate. Important factors include having significant artery narrowing confirmed by imaging and not having recent major surgery or certain heart conditions. Please review eligibility criteria for more details.

Is there any cost to participate in this carotid artery stenosis clinical trial?

Study-related care, including the stent device and all trial visits, is provided at no cost. However, personal travel expenses and other costs may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID07370246

Study of a Carotid Artery Stent System for Treating Narrowing With High-risk Features for Carotid Endarterectomy in China

Led by Beijing Tiantan Hospital · Updated on 2026-04-14

212

Participants Needed

Research Sites

52 weeks

Total Duration

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

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