CAS for Stenosis With High-risk Features for CEA (NCT07370246) | Clinical Trial Compass
RecruitingNot Applicable
CAS for Stenosis With High-risk Features for CEA
China212 participantsStarted 2026-03-06
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years, male or female;
✓. 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;
✓. 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;
✓. The vessel diameter of the target lesion is between 3.0 mm and 9.0 mm;
✓. Voluntary participation in this trial and provision of written informed consent.
✓. Age ≥ 75 years at the time of enrollment;
✓. Patients with congestive heart failure (New York Heart Association Class III/IV);
✓. Patients with unstable angina pectoris;
Exclusion criteria
✕. Target lesions caused by carotid arteritis;
✕. Target lesions located at the origin of the common carotid artery;
✕. Target lesions with extensive calcification or excessive tortuosity that preclude stent delivery;
What they're measuring
1
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
Timeframe: 30 days after the procedure and 365 days after the procedure
. Target lesions attributable to asymptomatic complete occlusion or the presence of a "string sign";
✕. Target lesions adjacent to significant acute or subacute thrombus, or arteriovenous malformation;
✕. 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;
✕. History of intracranial hemorrhage or progressive stroke within 3 months before the procedure;
✕. History of an extensive hemispheric stroke within 2 weeks before the procedure;