Determining Predictors of Restenosis. Intravascular Ultrasound in the Treatment of Femoropopliteal Lesions
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 主要终点
- In Stent Restenosis
研究概览
简要总结
A prospective, single-center, real-world study on intravascular ultrasound measurements after percutaneous transluminal angioplasty and stenting in the treatment of femoropopliteal lesions.
详细描述
Intravascular ultrasound is considered important tool in endovascular procedures of coronary territory. Information such as vessel diameter, stent expansion, residual stenosis, helped in better understanding of the disease, treatment and stent behavior.
However, as a different anatomical territory with major hemodynamic differences, many of these concepts could not be reproduced in the femoropopliteal segment.
The purpose of this study is to correlate data collected by intraoperative intravascular ultrasound after the angioplasty procedure with stent placement in femoropopliteal arterial lesions and patency of this revascularization within 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stenotic (>50%) or occlusive atherosclerotic disease of the femoropopliteal arteries;
- •Successful lesion passage passed with conventional mechanical guidewires;
- •Symptomatic critical limb ischemia (Rutherford 4, 5, 6);
- •Life-expectancy of more than 12 months;
- •Tha patient must be willing and able to return to the appropriate follow-up times for the duration of the study;
- •Te patient must provide written patient informed consent that is approved by the ethics committee.
排除标准
- •Patient refusing treatment;
- •The reference segment diameter is not suitable fo available balloon and/or stent design;
- •Unsuccessfully treated (>30% residual stenosis) proximal inflow limiting arterial stenosis;
- •Previously implanted stent(s) or percutaneous transluminal angioplasty at the same lesion site;
- •The patient has a known allergy to heparin, Aspirin or other anticoagulant/antiplatelet therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies;
- •The patent has a history of prior life-threatening contrast media reaction;
- •The patient is currently enrolled in another investigational device or drug trial;
- •The patient is currently breast-feeding, pregnant or intends to become pregnant;
- •The patient is mentally ill or retarded.
结局指标
主要结局
In Stent Restenosis
时间窗: 12 months (±30 days)
Stent Expansion Ratio Measure
时间窗: intraoperative
defined as = minimum stent cross-sectional area ÷ reference lumen cross-sectional area
Axial Stent Symmetry Index Measure
时间窗: intraoperative
defined as = minimum ÷ maximum stent cross-sectional area
Stent/reference Diameter Ratio Measure
时间窗: intraoperative
defined as = stent diameter ÷ reference diameter
Plaque Burden Measure
时间窗: intraoperative
defined as = (external elastic membrane cross-sectional area - lumen cross-sectional area) ÷ external elastic membrane cross-sectional area
Radial Stent Symmetry Index Measure
时间窗: intraoperative
defined as = minimum ÷ maximum stent diameter at minimum stent cross-sectional area
Reference Lumen Measure
时间窗: intraoperative
defined as = (proximal reference lumen cross-sectional area + distal reference lumen cross-sectional area) x 0.5
Reference Diameter Measure
时间窗: intraoperative
defined as = (proximal reference diameter + distal reference diameter) x 0.5
次要结局
- Freedom of reintervention at each follow-up(12 months (±30 days))
- Technical success(intraoperative)
- Limb-salvage rate(12 months (±30 days))
- Clinical success at follow-up(12 months (±30 days))
- Serious adverse events(12 months (±30 days))
研究者
Martin Andreas Geiger
Vascular Surgeon
University of Campinas, Brazil