This randomized controlled trial aims to evaluate whether a proximal-distal dual cerebral protection strategy can reduce the occurrence of new cerebral ischemic lesions compared with a single cerebral protection strategy in patients undergoing carotid artery stenting. Eligible participants will be randomly assigned to receive either dual cerebral protection using proximal flow control combined with a distal embolic protection device or conventional single cerebral protection. Brain magnetic resonance imaging will be performed after the procedure to assess new ischemic lesions. The study will also evaluate peri-procedural neurological events and other safety and efficacy outcomes.
Age 18 to 80 years, regardless of sex.
Symptomatic carotid artery stenosis ≥50% or asymptomatic carotid artery stenosis ≥70%, with the degree of stenosis determined according to the prespecified NASCET method and confirmed by CTA, DSA, or MRA.
Presence of at least one protocol-defined complex high-risk carotid stenosis feature confirmed by carotid ultrasonography, CTA, DSA, HR-VWI, or other protocol-specified imaging modalities.
Written informed consent provided by the participant or legally authorized representative.
Other cerebrovascular lesions that may substantially increase peri-procedural risk or interfere with assessment of the primary outcome, including an untreated ipsilateral intracranial aneurysm >5 mm, cerebral arteriovenous malformation, dural arteriovenous fistula, or other vascular lesions considered to pose significant risk by multidisciplinary assessment.
Severe ipsilateral intracranial tandem stenosis ≥70% that is related to a recent ischemic event, is planned for intervention during the study follow-up period, or may interfere with attribution of post-procedural stroke; or complete occlusion of the contralateral internal carotid artery with an unacceptable risk of intolerance to proximal flow arrest.
Technical conditions precluding carotid artery stenting or preventing safe implementation of either randomized cerebral protection strategy, including target-vessel occlusion or near-occlusion with distal collapse; free-floating thrombus or high-burden active intraluminal thrombus; absence of an appropriate landing zone for the distal embolic protection device or balloon flow-control segment in the common carotid artery; inability to safely cross, deploy, or retrieve the distal protection device; inability to safely and stably position the balloon guide catheter; severe aortic arch, supra-aortic, carotid-origin, or iliofemoral disease resulting in unacceptable transfemoral access risk; severe vascular tortuosity, angulation, or calcification resulting in unacceptable device-passage, vascular-injury, or stent-deployment risk; unacceptable risk of intolerance to proximal flow arrest; or any other condition preventing safe implementation of either randomized strategy.
Previous stenting, angioplasty, or other endovascular mechanical treatment of the target carotid artery; or carotid lesions not prespecified for inclusion in the etiologic complex-lesion cohort, including carotid dissection, vasculitis, traumatic or infectious lesions, pseudoaneurysm, or fibromuscular dysplasia other than carotid web.
Parallel
BGC proximal flow control plus distal filter embolic protection device during carotid artery stenting
Procedure/SurgeryCarotid artery stenting will be performed via a transfemoral approach. Proximal flow control will be established using a balloon guide catheter (BGC) and combined with a distal filter embolic protection device. Carotid artery stenting will then be completed under dual proximal and distal cerebral protection.
Single distal filter embolic protection device during carotid artery stenting
Procedure/SurgeryCarotid artery stenting will be performed according to a standardized procedure under the protection of a distal embolic protection device. The selection criteria for the distal protection device and stent will be consistent with those used in the experimental group. The brand, model, size, rationale for selection, and details of device use will be fully
Proportion of Participants With at Least One New Ipsilateral Cerebral Ischemic Lesion on Diffusion-Weighted MRI
The primary outcome is the proportion of participants with at least one new cerebral ischemic lesion on the side of the target carotid artery detected by diffusion-weighted magnetic resonance imaging (DWI) after carotid artery stenting, compared with the pre-procedural baseline MRI. New ischemic lesions will be assessed by an independent central imaging core laboratory blinded to treatment allocation.
Composite of Any Stroke or All-Cause Death Within 30 Days
First occurrence of any stroke or all-cause death within 30 days after carotid artery stenting. Clinical events will be adjudicated by an independent Clinical Events Committee blinded to treatment allocation.
Number and Distribution of New Cerebral Ischemic Lesions on Diffusion-Weighted MRI
The number and distribution of new cerebral ischemic lesions detected on post-procedural diffusion-weighted MRI compared with the pre-procedural baseline MRI. Distribution of new ischemic lesions according to laterality (ipsilateral or contralateral to the target carotid artery) and vascular territory involvement (single or multiple vascular territories). Lesions will be assessed by an independent central imaging core laboratory blinded to treatment allocation.
Characteristics of New Cerebral Ischemic Lesions on Diffusion-Weighted MRI
New cerebral ischemic lesions will be classified as cortical or subcortical. Lesions will also be categorized according to the maximum lesion diameter.
Proportion of Participants With New Symptomatic or Asymptomatic Cerebral Infarction
The proportions of participants with newly developed symptomatic cerebral infarction and newly developed asymptomatic cerebral infarction after carotid artery stenting will be assessed separately. Symptomatic cerebral infarction is defined as a new cerebral infarction associated with corresponding new neurological symptoms, whereas asymptomatic cerebral infarction is defined as a new cerebral infarction without corresponding new neurological symptoms.
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Xuanwu Hospital, Beijing
Lead sponsor
Union hospital of Fujian Medical University
Collaborator
Fujian Zhangzhou hospital
Collaborator
People's Hospital of Gaomi City
Collaborator
The First Affiliated Hospital of Haerbin Medical University
Collaborator
Henan Provincial People's Hospital
Collaborator
Heze Municipal Hospital
Collaborator
Jiangsu Provincial People's Hospital
Collaborator
Linyi People's Hospital
Collaborator
The First People's Hospital of Mianyang
Collaborator
Nanyang Central Hospital
Collaborator
Shandong Provincial Hospital
Collaborator
Shanxi Cardiovascular Hospital
Collaborator
Jinan Hospital, Xuanwu Hospital, Capital Medical University
Collaborator
Tianjin Huanhu Hospital
Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital
Collaborator
Xinqiao Hospital
Collaborator
Baoji third people's hospital
Collaborator
Liaocheng People's Hospital
Collaborator
Liaocheng Brains Hospital / Liaocheng People's Hospital
Collaborator
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