CLEAR-ROAD; a Physician-initiated Carotid Trial Investigating the Efficacy of Endovascular Treatment of Carotid Arterial Disease With the Multi-layer RoadSaver Stent
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 8
- 主要终点
- 30-day rate of Major Adverse events (MAE)
研究概览
简要总结
The objective of this clinical investigation is to evaluate the clinical outcome (up to 12 months) of treatment by means of stenting with the RoadSaver (Terumo) in subjects at high risk for carotid endarterectomy requiring carotid revascularization due to significant extra-cranial carotid artery stenosis.
详细描述
It is a Prospective, multi-center, physician-sponsored clinical study.
The objective of this clinical investigation is to evaluate the clinical outcome (up to 12 months) of treatment by means of stenting with the RoadSaver (Terumo) in subjects at high risk for carotid endarterectomy requiring carotid revascularization due to significant extra-cranial carotid artery stenosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •High risk for carotid endarterectomy due to anatomical or co-morbid conditions and either:
- •has neurological symptoms and ≥ 50% stenosis via angiography, or
- •is asymptomatic and has ≥ 80% stenosis via angiography.
- •Target lesion located in the distal common carotid artery (CCA), internal carotid artery (ICA), or carotid bifurcation.
- •Arterial segment to be stented has a diameter between 4mm and 9mm
- •Age ≥ 18 years.
- •Life expectancy > 12 months from the date of the index procedure.
- •Provides a signed, IRB (Institutional Review Board) / IEC (Institutional Ethical Committee) approved informed consent form prior to participation.
- •Willing and able to comply with follow-up requirements.
排除标准
- •Contra-indication to percutaneous transluminal angioplasty (PTA).
- •Sever vascular tortuosity or anatomy that would preclude the safe introduction of a guide catheter, sheath, embolic protection system or stent system.
- •Lesions in the ostium of the common carotid artery.
- •Occlusion of the target vessel.
- •Evidence of intraluminal thrombus.
- •Known sensitivity to nickel-titanium.
- •Known allergy to heparin, aspirin or other anticoagulant/antiplatelet therapies, or is unable or unwilling to tolerate such therapies.
- •Uncorrectable bleeding disorders, or will refuse block transfusion.
- •History of prior life-threatening contrast media reaction.
- •Previous stent placement in the target vessel.
- •Evolving stroke or intracranial haemorrhage.
- •Previous intracranial haemorrhage or brain surgery within the past 12 months.
- •Clinical condition that makes endovascular therapy impossible or hazardous.
研究组 & 干预措施
RoadSaver stent
patient treated with the RoadSaver stent of Terumo
干预措施: RoadSaver stent (Device)
结局指标
主要结局
30-day rate of Major Adverse events (MAE)
时间窗: 30 days
The primary endpoint of this study is the 30-day rate of major adverse events (MAE), defined as the cumulative incidence of any peri-procedural (≤ 30 days post-procedure) death, stroke or myocardial infarction (MI).
次要结局
- Late Ipsilateral stroke(day 31 through 365 days)
- Major Adverse Events (MAE's)(at 1,6 and 12 month follow-up)
- System Technical Success(procedure (day 0))
- device malfunctions(procedure (day 0))
- serious device-related and procedure-related Adverse Events (SAE's)(at 1, 6 and 12 month follow-up)
- in-stent restenosis (ISR)(at 1, 6 and 12 month follow-up)
- freedom from Target Lesion Revascularization (TLR)(at 1, 6 and 12-month follow-up)