Plaque Prolapse Prevention Carotid Artery Stenting (3PCAS) Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- perioperative (intraoperative and up to 72 hours postoperatively) neurological ischemic events clinically detectable.
研究概览
简要总结
The aim of the present positive-control study is to analyze and compare the rate of off-table subclinical neurological events in two groups of patients submitted to carotid artery stenting (CAS) with two different kind of stents, a close-cell stent, and the new mesh-covered stent, so to verify if the new model of stent is effective in preventing postprocedural carotid plaque embolism.
详细描述
Scientific background and explanation of rationale: CAS in selected asymptomatic patients has proven to be effective in reducing the risk of carotid-related neurological ischemic events in selected patients. It also carries a not-negligible risk of intraprocedural and postprocedural (so-called "off-table") embolic events causing clinical (TIA, stroke, death) and subclinical (Magnetic Resonance Imaging - MRI-detectable microembolic brain lesions, cognitive impairment, increase in markers of brain injury) morbidity. CAS technique has progressively refined in order to minimize the risk of intraprocedural embolism, but despite the increasing use of close-cell design stents the risk of plaque prolapse through the stent struts and of postprocedural embolism still exists. In order to prevent plaque prolapse a new stent design has been conceived and realized. It combines the traditional open-cell design to an exterior PET mesh that is able to capture and keep in place plaque debris as small as 150-180µm.
The aim of the present positive-control study is to analyze and compare the rate of off-table subclinical neurological events in two groups of patients submitted to CAS with two different kind of stents, a close-cell stent, and the new mesh-covered stent, so to verify if the new model of stent is effective in preventing postprocedural carotid plaque embolism.
Methods
Trial Design: single-center, superiority, randomized controlled trial comparing results between two different carotid stents in patients affected by asymptomatic ≥70% carotid artery stenosis.
Participants:
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)
入排标准
- 年龄范围
- 55 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •presence of a carotid stenosis ≥70% (NASCET evaluation criteria)
- •no previous neurologic symptoms referred in the medical history
- •absence of a previous brain ischemic lesion detected at DW-MRI
排除标准
- •symptomatic carotid lesions
- •previous ischemic brain lesions detected at DW-MRI
- •inability to give consent
- •Exclusion criteria for CAS are:
- •significant contraindications to angiography,
- •history of bleeding disorder,
- •intracranial aneurysm or vascular malformation or hemorrhage,
- •presence of intraluminal thrombus,
- •poor entry points at the femoral artery,
- •type 2-3 arch,
- •bovine arch,
- •severe aortic arch or ipsilateral ostial common carotid or brachiocephalic atherosclerosis,
- •severe proximal common or distal internal carotid artery tortuosity,
- •sharply angulated internal carotid artery,
- •carotid string sign,
- •circumferential calcification of carotid plaque,
- •length of the target lesion requiring more than one stent
研究组 & 干预措施
C-Guard carotid stent
Carotid stenting procedure by C-Guard stent implantation (InspireMD, Boston, MA, USA)
干预措施: Carotid stenting procedure by carotid stent implantation (Procedure)
Wallstent carotid stent
Carotid stenting procedure by Wallstent implantation (BostonScientific, Marlborough, MA, USA)
干预措施: Carotid stenting procedure by carotid stent implantation (Procedure)
结局指标
主要结局
perioperative (intraoperative and up to 72 hours postoperatively) neurological ischemic events clinically detectable.
时间窗: intraoperative and up to 72 hours postoperatively
perioperative (intraoperative and up to 72 hours postoperatively) neurological ischemic events clinically (TIA, stroke, permanent focal retinal artery occlusion, neurological death).
perioperative (intraoperative and up to 72 hours postoperatively) neurological ischemic events subclinically detectable.
时间窗: intraoperative and up to 72 hours postoperatively
perioperative (intraoperative and up to 72 hours postoperatively) neurological ischemic events subclinically detectable (by new DW-MRI lesions, ≥0.02 µg/L increase in S100β and/or ≥0.3 µg/L increase in NSE serum levels, ≥5 variation in postprocedural MiniMentalStateExaminationTest -MMSE score).
次要结局
- local (inguinal haemathoma, pseudoaneurysm formation, access vessel dissection or thrombosis) complications occurring during or after procedure.(intraoperative and up to 72 hours postoperatively)
- systemic complications occurring during or after procedure.(intraoperative and up to 72 hours postoperatively)
研究者
Laura Capoccia
Vascular and Endovascular Surgery Division, Department of Surgery
University of Roma La Sapienza