MARIS - Prospective, Multicenter Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,051
- 主要终点
- target lesion revascularization
研究概览
简要总结
The MARIS Register is a prospective, multicenter registry of implantation in the superficial femoral artery (SFA) with a CE marked stent (Maris / Invatec) intended to capture initial angiographic success, complication rate and symptomatic related revascularization by following the clinical process and duplex examinations at 6 and 12 month.
详细描述
Recent data suggest that there is some evidence for a reduced restenosis rate for the implantation of a self expanding nitinol stent in the superficial femoral artery (SFA) compared to implantation of balloon expandable stents or single balloon inflation (ABSOLUTE study/FAST study).
The purpose of the Maris Register is to evaluate the primary nitinol stent implantation in an all comer population with diseased SFA.
The MARIS Register is a prospective, multicenter registry of the implantation of at least one at most five nitinol stents (Maris / Invatec) in the SFA without limitations for stenosis or occlusion length.
The registry includes 998 patients from 13 German investigational sites. Clinical data are captured on electronic case report forms
The primary endpoint is the target lesion revascularization after 12 month
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
- •stent implantation in SFA is possible
- •existing SFA stenosis 70-100 % (visual estimation)
- •absence of homodynamically relevant stenosis in A. poplitea
- •at least one lower limb run off vessel
排除标准
- •pregnancy
- •life expectancy less than 1 year
- •coagulation disorder
- •chronic anticoagulation therapy
- •active gastrointestinal bleeding
- •thrombolytic therapy within 72 hours before intervention
- •hyperthyreosis
- •severe contrast agent allergy
- •allergy to concomittant medication
- •severe liver disease
- •thrombus in target lesion
- •target lesion extend into A. poplitea
- •severe calcification of target vessel, where no successful pre-dilatation is feasible
结局指标
主要结局
target lesion revascularization
时间窗: 1 year
次要结局
- Restenosis rate > 50% according to ultrasound criteria(6 and 12 month)
- Restenosis rate > 70% according to ultrasound criteria(6 and 12 month)
- Location of restenosis (proximal, middle, distal AFS)(6 and 12 month)
- Number of stent fractures (grading according to FESTO criteria)(12 month)
- Procedure related complication rate(Discharge)
- Vascular complication rate within 12 month(12month)
- Amputations within 12 month(12month)
- Deaths within 12 month(12month)