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Clinical Trials in China / NCT07370246
Recruiting Not applicable

CAS for Stenosis With High-risk Features for CEA

NCT07370246 · tracked via the Priya Life Science China tracker
Sponsor
Beijing Tiantan Hospital
Phase
Not applicable
Started
2026-03-06
Last updated
2026-04-14

Condition(s) studied

Carotid Artery StenosisCarotid Artery Stenting

Investigational drug(s) / intervention(s)

Carotid artery stent system

Carotid 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).

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥ 18 years, male or female; 2. Pre-procedural carotid duplex ultrasound and/or computed tomography angiography confirmed stenosis of the common carotid artery, internal carotid artery, or carotid bifurcation, and are considered suitable for endovascular treatment; 3. Intra-procedural digital subtraction angiography, using NASCET criteria, confirmed stenosis of ≥ 50% (symptomatic) or ≥ 80% (asymptomatic), and symptomatic is defined as the occurrence of one or more clinical events within 6 months prior to the procedure, including transient ischemic attack, amaurosis fugax, or minor/non-disabling stroke attributable to the ipsilateral intracranial circulation; 4. The vessel diameter of the target lesion is between 3.0 mm and 9.0 mm; 5. Voluntary participation in this trial and provision of written informed consent. Inclusion criteria for high-risk features for carotid endarterectomy: Comorbidity factors: 1. Age ≥ 75 years at the time of enrollment; 2. Patients with congestive heart failure (New York Heart Association Class III/IV); 3. Patients with unstable angina pectoris; 4. Patients with severe chronic obstructive pulmonary disease, defined as an FEV1 ≤ 50% of predicted, requirement for chronic oxygen therapy, or a resting PO₂ ≤ 60 mmHg; 5. Patients with left ventricular ejection fraction ≤ 30%; 6. Patients with recent myocardial infarction (within 2 to 6 weeks); 7. Patients with coronary artery disease with ≥ 70% stenosis in two or more major vessels; 8. Planned coronary artery bypass grafting or valve replacement surgery within 31 to 60 days following the procedure. Anatomical factors: 1. Lesions located at or above the level of the second cervical vertebra (C2) or lesions that are surgically inaccessible below the clavicle; 2. History of radical head and neck surgery or radiotherapy; 3. Patients with limited cervical spine mobility; 4. Patients with tracheostomy; 5. History of vocal cord paralysis or laryngectomy; 6. Patients with contralateral recurrent laryngeal nerve palsy; 7. Patients with restenosis following previous carotid endarterectomy; 8. Patients with severe stenosis or occlusion of the contralateral carotid artery; 9. Severe tandem lesions that can be covered by a single stent. Exclusion Criteria: 1. Target lesions caused by carotid arteritis; 2. Target lesions located at the origin of the common carotid artery; 3. Target lesions with extensive calcification or excessive tortuosity that preclude stent delivery; 4. Target lesions attributable to asymptomatic complete occlusion or the presence of a "string sign"; 5. Target lesions adjacent to significant acute or subacute thrombus, or arteriovenous malformation; 6. History of major surgery (including intra-abdominal, intrathoracic, cardiac, or vascular procedures) within 30 days before the procedure, or any such surgery scheduled within 30 days after the procedure; 7. History of intracranial hemorrhage or progressive stroke within 3 months before the procedure; 8. History of an extensive hemispheric stroke within 2 weeks before the procedure; 9. History of bradycardia (heart rate \< 40 bpm) before the procedure; 10. History of paroxysmal atrial fibrillation within the past 6 months, or paroxysmal atrial fibrillation requiring long-term anticoagulation therapy; 11. Patients with known or potential sources of thromboembolism (including previously known symptomatic patent foramen ovale, mechanical heart valves, or deep vein thrombosis treated within 6 months); 12. Patients with a known intracranial aneurysm requiring surgical intervention that cannot be treated before the procedure; 13. Patients with known coagulation disorders (APTT \> 3 times the upper limit of normal) or abnormal bleeding disorders; 14. Patients with known contraindications to heparin or antiplatelet agents; 15. Patients with a platelet count \< 100×10\^9/L; 16. Patients with known allergies to any components of the investigational product, contrast agents; 17. Patients with known severe hepatic or renal insufficiency (ALT or AST \> 5 times the upper limit of normal, or serum creatinine \> 3 times the upper limit of normal); 18. Patients with known uncontrolled severe hypertension (persistent systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg); 19. Patients with a pre-procedure mRS score \> 3; 20. Patients with extensively metastatic malignancy; 21. Patients concurrently enrolled in another drug or medical device clinical trial; 22. Female patients who are currently pregnant or breastfeeding, or who plan to conceive within 1 year; 23. Lesions inaccessible by endovascular approach (including severe tortuosity of aortic arch branches with no suitable access artery, or special aortic arch anatomy); 24. According to the judgment of the investigator, patients with an expected survival of less than 12 months; 25. According to the judgment of the investigator, other situations that are not suitable for enrollment.

Primary outcome measure(s)

Trial sites (16)

FacilityCityRegionStatus
Beijing Tiantan Hospital, Affiliated to Capital Medical University Beijing Beijing Municipality Recruiting
Chongqing University Three Gorges Hospital Chongqing Chongqing Municipality Recruiting
The Second Nanning People's Hospital Nanning Guangxi Recruiting
The Affiliated Hospital of Guizhou Medical University Guiyang Guizhou Recruiting
Hebei General Hospital Shijiazhuang Hebei Recruiting
Xingtai Central Hospital Xingtai Hebei Recruiting
Tongji Hospital, Affiliated to Tongji Medical College of Huazhong University of Science and Technology Wuhan Hubei Recruiting
Inner Mongolia Autonomous Region People's Hospital Hohhot Inner Mongolia Recruiting
Jiu Jiang No.1 People's Hospital Jiujiang Jiangxi Recruiting
The First Bethune Hospital of Jilin University Changchun Jilin Recruiting
Jining First People's Hospital Jining Shandong Recruiting
The Affiliated Hospital of Qingdao University Qingdao Shandong Recruiting
The First Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang Recruiting
Lishui Central Hospital Lishui Zhejiang Recruiting
Taizhou Hospital of Zhejiang Province Taizhou Zhejiang Recruiting
The Taizhou First People's Hospital Taizhou Zhejiang Recruiting

More Beijing Tiantan Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07370246 on ClinicalTrials.gov ↗ ← All trials in China