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)
Stroke, myocardial infarction, and death within 30 days after the procedure, or stroke in the territory of the ipsilateral artery between day 31 and day 365 after the procedure — 30 days after the procedure and 365 days after the procedure Stroke is defined as an event that causes focal neurological dysfunction or signs and lasts for at least 24 hours, including ischemic stroke and hemorrhagic stroke. Myocardial infarction is defined as an increase in creatine kinase isoenzyme (CK-MB) or troponin in the postoperative period that is at least twice the upper limit of the normal range, accompanied by ischemic symptoms such as chest pain, or the presence of ischemic electrocardiogram evidence. Ischemic stroke in the territory of the ipsilateral artery is defined as an ischemic stroke in the cerebral hemisphere that is supplied with blood flow by the target artery.
Trial sites (16)
Facility
City
Region
Status
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
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.
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