CAS for Stenosis With High-risk Features for CEA
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Tiantan Hospital
About this trial
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 criteria
Qualifiers
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;
Disqualifiers
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;
Target lesions attributable to asymptomatic complete occlusion or the presence of a "string sign";
Trial design
Treatments tested in this trial
- Carotid artery stent system
Treatment groups
212 Participants
are divided into 1 treatment groupSponsors and collaborators
Beijing Tiantan Hospital
Lead sponsor
Shanghai HeartCare Medical Technology Co., Ltd.
Collaborator
Source ClinicalTrials.gov