NCT00798512已完成不适用
DESERVE: Diffusion Weighted-MRI Based Evaluation of the Effectiveness of Endovascular Clamping During Carotid Artery Stenting With the Mo.Ma Device. A Prospective, Multicenter Study.
Invatec S.p.A.11 个研究点 分布在 3 个国家目标入组 127 人开始时间: 2008年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 127
- 试验地点
- 11
- 主要终点
- The de-novo occurrence of intra-cerebral lesions per patient by comparing baseline (within 1 week prior procedure) and post-procedural DW-MRI (from 3 to 12 hours post procedure).
研究概览
简要总结
The purpose of this study is to detect new ischemic lesions after carotid artery stenting (with the Cristallo Ideale stent), in patients with high grade carotid artery stenosis, by diffusion-weighted magnetic resonance imaging (DW-MRI), using the endovascular proximal flow blockage (Mo.Ma device) for cerebral protection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •≥ 18 years old;
- •Eligibility for carotid artery revascularization;
- •A significant stenosis in symptomatic patients with ≥ 50% Diameter Stenosis (%DS) or asymptomatic ≥ 80 %DS as defined by angiography.
- •Symptomatic is defined as a carotid artery stenosis associated with ipsilateral TIA, amaurosis fugax, ischemic stroke or retinal infarction within 6 months prior to enrollment.
- •Suitable clinical conditions to perform DW-MRI.
- •Written informed consent as approved by the Ethics Committee of the respective clinical site.
排除标准
- •Female with childbearing potential without a negative pregnancy test.
- •Life-expectancy less than 6 months.
- •Underlying disease of the carotid artery other than atherosclerosis (e.g. vasculitis, traumatic dissection, fibromuscular dysplasia).
- •Prior stenting in the target vessel;
- •Patients with chronic or re-current atrial fibrillation.
- •Patient has had a Myocardial Infarction within 72 hours prior to the procedure.
- •Patient experienced a stroke within 4 weeks prior to the procedure.
- •History of severe disabling stroke according to the modified Rankin scale >
- •Severe renal failure (serum creatinine > 2.0 mg/dL).
- •Severe peripheral arterial occlusive disease, which might impede a safe introduction of a 9F-sheath for the use of a Mo.Ma-device.
- •Any known allergies and / or intolerances to the following: ASA, Clopidogrel, Statins, Heparin, Nitinol, contrast agents (that cannot be adequately pre-medicated).
- •Patient currently participating in an investigational drug or device study which has not reached the primary endpoint yet or which clinically interferes with the DESERVE study endpoints.
- •Any planned major surgery within 30 days after the study procedure.
- •In the investigators opinion patient has a severe co-morbid condition(s) that could limit the ability to participate in the study.
- •Angiographic exclusion criteria:
- •Totally occluded internal carotid artery considered as the target vessel.
- •Multiple internal carotid artery stenoses or lesion longer than 4 cm (whichever occurs) that cannot be covered by one (1) stent.
- •Severe ostial stenosis of the common carotid artery.
- •The presence of ipsilateral intracranial stenosis that requires treatment.
- •Contralateral occlusion of the internal carotid arteries associated with a poor collateral flow through the circle of Willis.
- •An aortic arch anatomical complexity that may preclude the safe placement of the Mo.Ma device including particularly, the impossibility to navigate a stiff guide wire into the external carotid artery.
结局指标
主要结局
The de-novo occurrence of intra-cerebral lesions per patient by comparing baseline (within 1 week prior procedure) and post-procedural DW-MRI (from 3 to 12 hours post procedure).
时间窗: 3-12 hours after index procedure
次要结局
- Device Success; Technical Success; Procedural Success; Restenosis rate at 30 days follow up; TLR at 30 days follow up; Access Site Complications; MACCE at 30 days; Incidence of TIA up to 30 days.(30 days)
研究者
研究点 (11)
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