Balloon Guide Catheter-Mediated Proximal Flow Control Plus Distal Embolic Protection Versus Distal Embolic Protection Alone During Carotid Artery Stenting in Patients With Complex High-Risk Carotid Stenosis-A Multicentre, Randomised, Open-Label, Blinded Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Proportion of Participants With at Least One New Ipsilateral Cerebral Ischemic Lesion on Diffusion-Weighted MRI
研究概览
简要总结
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.
详细描述
Carotid artery stenting is an established treatment for selected patients with carotid artery stenosis, but peri-procedural cerebral embolization remains an important concern. Distal embolic protection devices are commonly used during carotid artery stenting; however, embolization may occur during lesion crossing or device manipulation before complete distal protection is established.
The CEST-PROTECT trial is a prospective, multicenter, randomized controlled study designed to investigate whether a proximal-distal dual cerebral protection strategy provides additional cerebral protection compared with a conventional single protection strategy during carotid artery stenting. Participants will be randomly assigned to the dual-protection group or the single-protection group.
In the dual-protection group, proximal flow control will be combined with a distal embolic protection device during carotid artery stenting. In the single-protection group, carotid artery stenting will be performed using conventional distal embolic protection alone.
Brain magnetic resonance imaging, including diffusion-weighted imaging, will be performed after the procedure to identify new cerebral ischemic lesions. Clinical neurological outcomes, procedural outcomes, and safety events will also be assessed during follow-up. The study is intended to determine whether the dual-protection strategy can reduce peri-procedural cerebral embolic injury without increasing procedure-related complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes assessor blinded: Participants, treating physicians, and investigators will not be masked to treatment allocation because of the nature of the procedural intervention. Outcome assessors will be blinded to treatment allocation. Imaging outcomes will be evaluated by an independent central imaging core laboratory, clinical events by a blinded Clinical Events Committee, and neurological outcomes by trained independent blinded assessors.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •Modified Rankin Scale (mRS) score ≥3 after a recent stroke, or the presence of a large cerebral infarction, significant cerebral edema or mass effect, hemorrhagic transformation, impaired consciousness, progressive neurological deficits, or clinically unstable neurological status.
- •Contraindication to contrast agents, antiplatelet therapy, anticoagulant therapy, or medications required during the procedure that cannot be adequately managed; or inability or expected inability to receive or complete protocol-required dual antiplatelet therapy.
- •A recent ischemic event considered primarily cardioembolic, or the presence of a high-risk cardiac source of embolism such as left atrial or left ventricular thrombus, infective endocarditis, a mechanical heart valve with inadequate anticoagulation, or an intracardiac mass. Atrial fibrillation alone is not an absolute exclusion criterion unless it is considered the primary cause of the qualifying ischemic event or required anticoagulation cannot be safely combined with the protocol-required antiplatelet regimen.
- •A serious medical condition precluding elective carotid artery stenting, including active bleeding, uncorrectable coagulopathy, severe renal dysfunction without adequate risk-control measures, persistent uncontrolled severe hypertension, active severe infection, myocardial infarction within 6 weeks before screening, unstable acute coronary syndrome, decompensated heart failure, uncontrolled severe arrhythmia, or another serious systemic disease.
- •Contraindication to MRI or anticipated inability to complete the protocol-required baseline and post-procedural MRI/DWI examinations.
- •Current participation, or participation within 3 months before screening, in another clinical study that may affect the study intervention, safety assessment, or primary outcome evaluation; or planned major surgery or endovascular treatment during the peri-procedural period or 30-day follow-up that may interfere with assessment of study outcomes.
- •Inability to understand or comply with study procedures, provide valid informed consent, complete the 30-day clinical follow-up or neurological assessments, or provide reliable primary outcome data; or life expectancy shorter than the required study follow-up period.
- •Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study, substantially increases study-related risk, or may compromise the reliability of the study results.
研究组 & 干预措施
BGC proximal flow control plus distal filter embolic protection device
Carotid 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, allowing the procedure to be performed under dual proximal and distal cerebral protection
干预措施: BGC proximal flow control plus distal filter embolic protection device during carotid artery stenting (Procedure)
Single distal filter embolic protection device
Carotid 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 documented.
干预措施: Single distal filter embolic protection device during carotid artery stenting (Procedure)
结局指标
主要结局
Proportion of Participants With at Least One New Ipsilateral Cerebral Ischemic Lesion on Diffusion-Weighted MRI
时间窗: Within 72 hours after carotid artery stenting
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.
次要结局
- Composite of Any Stroke or All-Cause Death Within 30 Days(Within 30 (±7) days after carotid artery stenting)
- Number and Distribution of New Cerebral Ischemic Lesions on Diffusion-Weighted MRI(Within 72 hours after carotid artery stenting)
- Characteristics of New Cerebral Ischemic Lesions on Diffusion-Weighted MRI(Within 72 hours after carotid artery stenting)
- Proportion of Participants With New Symptomatic or Asymptomatic Cerebral Infarction(Within 30 (±7) days after carotid artery stenting)
- Incidence of Ipsilateral Ischemic Stroke(Within 7 (±2) and 30 (±7) days after carotid artery stenting)
- Incidence of Ipsilateral TIA(Within 7 (±2) and 30 (±7) days after carotid artery stenting)
- Incidence of All-cause Death(Within 7 (±2) and 30 (±7) days after carotid artery stenting)
- NIHSS Score and Change From Baseline(At 7 (±2) days or hospital discharge, whichever occurs first, and at 30 (±7) days after carotid artery stenting)
- Modified Rankin Scale Score and Change From Baseline(At 30 (±7) days after carotid artery stenting)
- Incidence of Intracranial Hemorrhage(Within 72 hours after carotid artery stenting)
- Incidence of Adverse Events and Serious Adverse Events(Within 30 (±7) days after carotid artery stenting)
- Incidence of Device- or Procedure-Related Adverse Events(Within 30 (±7) days after carotid artery stenting)