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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Carotid artery stent system
DeviceThe 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).
Treatment groups
212 Participants
are divided into 1 treatment groupGroup A: Carotid artery stent systemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
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
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.
Time frame
30 days after the procedure and 365 days after the procedureSecondary outcomes
1
In-stent restenosis rate within 12 months after the procedure
Angiography demonstrated restenosis of the target artery both within the 5-mm stent segment and at the stent margins, with a degree of stenosis ≥50%.
Time frame
365 days after the procedure2
Implantation success rate
Implantation success was defined as successful implantation of the stent (including delivery, release, and expansion), covering the target lesion area, and subsequent withdrawal of the delivery system.
Time frame
During the procedure3
Procedure success rate
Procedure success is defined as successful stent implantation followed by angiographic confirmation of ≤30% residual stenosis at the target lesion and the absence of any major adverse event prior to hospital discharge.
Time frame
Before the discharge or 7 days after the procedure4
In-stent restenosis rate within 6 months after the procedure
Angiography demonstrated restenosis of the target artery both within the 5-mm stent segment and at the stent margins, with a degree of stenosis ≥50%.
Time frame
6 months after the procedureOther outcomes
1
Major adverse event rate
Major adverse events are defined as all deaths, strokes, and myocardial infarctions.
Time frame
30 days, 6 months, 12 months after the procedure2
Adverse events rate
Time frame
30 days, 6 months, and 12 months after the procedure3
Serious adverse events rate
Time frame
30 days, 6 months, and 12 months after the procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Beijing Tiantan Hospital
Lead sponsor
Shanghai HeartCare Medical Technology Co., Ltd.
Collaborator
Source ClinicalTrials.gov