RecruitingNot ApplicableNCT07370246

CAS for Stenosis With High-risk Features for CEA

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


Sponsor

Beijing Tiantan Hospital

Enrollment

212 participants

Start Date

Mar 6, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Carotid artery stent system for people with carotid artery stenosis and carotid artery stenting. The study is currently recruiting participants at 16 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECarotid artery stent system

The carotid artery stent system consists of a nitinol self-expanding stent and a 1.65mm (5F) delivery device. At the tip of the delivery device and the inner part of the distal outer tube, there is a guidewire channel. The proximal end of the guidewire channel stops at the guidewire exchange port. The design allows for the accommodation of a guidewire with a diameter of 0.014inch (0.36mm).


Locations(16)

Beijing Tiantan Hospital, Affiliated to Capital Medical University

Beijing, Beijing Municipality, China

Chongqing University Three Gorges Hospital

Chongqing, Chongqing Municipality, China

The Second Nanning People's Hospital

Nanning, Guangxi, China

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Hebei General Hospital

Shijiazhuang, Hebei, China

Xingtai Central Hospital

Xingtai, Hebei, China

Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Inner Mongolia Autonomous Region People's Hospital

Hohhot, Inner Mongolia, China

Jiu Jiang No.1 People's Hospital

Jiujiang, Jiangxi, China

The First Bethune Hospital of Jilin University

Changchun, Jilin, China

Jining First People's Hospital

Jining, Shandong, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Lishui Central Hospital

Lishui, Zhejiang, China

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, China

The Taizhou First People's Hospital

Taizhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT07370246


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