Biomechanical Characterization of Atherosclerotic Arterial Tissue of the Femoralis Superficialis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Axial force and diameter curves in function of pressure from extension-inflation tests on diseased superficial femoral arterial tissue.
研究概览
简要总结
The current treatment approaches for peripheral artery disease are largely unsatisfactory. Therefore, diseased tissue will be collected as well as patient-specific arterial geometries. The tissue will be tested microstructurally and mechanically to obtain data required to optimize treatment methods through in silico modeling.
详细描述
Peripheral artery disease (PAD) is a severe cause of morbidity in patients. Common treatment approaches are too often still unsatisfactory. Angioplasty is commonly followed by restenosis, caused by overloading of the arterial tissue. This study is aimed at improving this treatment approach through the in silico simulation of arterial remodeling after balloon expansion. Such simulations require the input of a patient-specific geometry and the mechanical properties of (diseased) arterial tissue.
Patients scheduled for an above knee lower limb amputation due to critical ischemia will be recruited in this study. After the surgery, the femoralis superficialis will be collected, as well as the CT or MR angiogram obtained before the surgery. The arterial tissue will be mechanically tested to obtain material properties and the medical image will be used to determine the arterial geometry. A correlation study will be carried out to explore the possibility of including a predictive simulation of the restenosis outcome of balloon angioplasty in the clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients suffering from critical ischemia in the lower limb and undergoing above-knee amputation
排除标准
- •The presence of any feature that will prevent tissue collection after the amputation
结局指标
主要结局
Axial force and diameter curves in function of pressure from extension-inflation tests on diseased superficial femoral arterial tissue.
时间窗: up to 3 years
Extension-inflation tests will be performed on the collected tissue. The results of these tests, in the form of axial force and diameter curves, will be fitted to existing or to be developed constitutive models describing the mechanical behavior of arterial tissue.
Biaxial stress-stretch curves of diseased superficial femoral arterial tissue from planar biaxial tension tests.
时间窗: up to 3 years
Planar biaxial tension tests will be performed on the collected tissue. The results of these tests, in the form of stress-stretch curves, will be fitted to existing or to be developed constitutive models describing the mechanical behavior of arterial tissue.
Reaction force curves in function of indentation depth from indentation tests on diseased superficial femoral arterial tissue.
时间窗: up to 3 years
Indentation tests will be performed on the collected tissue. The results of these tests, in the form of reaction force versus indentation depth curves, will be fitted to existing or to be developed constitutive models describing the mechanical behavior of arterial tissue.
次要结局
- Microstructural composition of diseased superficial femoral arterial tissue from histological analyses(up to 3 years)
- Microstructural composition of diseased superficial femoral arterial tissue from microCT analyses(up to 3 years)