The Impact of Optical Coherence Tomography on the Decision-making Process of Endovascular Treatment of Femoropopliteal Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Changed treatment planning based on OCT
研究概览
简要总结
Rationale: Peripheral arterial disease is a severe clinical problem with an increasing prevalence, due to an ageing population. Endovascular treatment, usually using stents, is recommended for most lesions in the femoropopliteal tract. The patency of these stents is influenced by several factors, including stent sizing and stent positioning.
Current procedural planning of femoropopliteal disease is primarily based on single-plane digital subtraction angiographies (DSA). This modality provides a 2-dimensional image of the vessel lumen, which may be suboptimal for stent sizing. It can therefore be difficult to choose the optimal stent position as minor lesions may be missed. Suboptimal treatment could result in unfavourable levels of wall shear stress causing the vessel wall to be more susceptible to neo-intimal hyperplasia ultimately causing restenosis and stent failure. Intravascular optical coherence tomography (OCT) is able to visualize the arterial wall with a micrometer resolution, which could result in better stent sizing. Furthermore, OCT is able to visualize different layers in the vessel wall and identify unhealthy areas, which may lead to a more optimal stent placement as unhealthy areas can be covered completely. Moreover, OCT provides detailed patient-specific geometries necessary to develop reliable computational fluid dynamics (CFD) models that simulate blood flow in stented arteries and calculate wall shear stresses, which could predict stent patency.
Objective: To investigate in a clinical study how often the use of intravascular optical coherence tomography for femoropopliteal stenotic lesions leads to alterations in treatment planning before and after stent placement, in comparison to traditional digital subtraction angiography-based treatment planning.
Study design: Exploratory observational study. Study population: 25 patients with femoropopliteal stenotic lesions who are treated with a Supera interwoven nitinol stent or Absolute nitinol stent.
Main study parameters/endpoints: The percentage of procedures in which OCT changed the DSA-based treatment planning before and after stent placement to investigate the impact of OCT imaging on treatment planning.
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
- •Aged 18 years of older
- •Written informed consent
- •Scheduled endovascular treatment of femoropopliteal stenotic lesions with a Supera interwoven nitinol stent or Absolute nitinol stent
- •Clinically and hemodynamically stable
排除标准
- •Occluded superficial femoral artery or popliteal artery
- •Superficial femoral artery and/or popliteal artery diameter larger than 6.5 mm
- •Severely impaired renal function (eGFR < 30 ml/min), end stage renal disease
- •Cardiac insufficiency (NYHA 3-4)
- •Hypersensitivity to iodinated contrast media
- •BMI > 25 and contralateral approach not possible
- •Minimal lumen diameter of target lesion < 1.5 mm
- •Presence of a hemodynamically significant inflow stenosis in the aorto-iliac tract or the common femoral artery
- •Participating in another trial with an investigational drug or medical device concerning the femoropopliteal tract interfering with the current study
- •Life expectancy of less than 24 months
- •Women of child-bearing age not on active birth control
- •Legally incapable
研究组 & 干预措施
Complete cohort
In all patients included in the study subsequent optical coherence tomography (OCT) measurements will be performed pre and post stent placement.
干预措施: Optical coherence tomography measurements (Device)
结局指标
主要结局
Changed treatment planning based on OCT
时间窗: Immediately following the procedure
The percentage of procedures in which the OCT changed the DSA-based treatment planning before and after stent placement to investigate the impact of OCT imaging on treatment planning.
次要结局
- Presence of artefacts in CTA scan(6-8 weeks after the procedure)
- Correlation CTA-based and OCT-based vessel lumen segmentations(Up to 2 years after the procedure)
- Velocity streamlines obtained from CTA-based CFD simulation(Up to 2 years after the procedure)
- Time averaged wall shear stress obtained from CTA-based CFD simulation(Up to 2 years after the procedure)
- Velocity streamlines obtained from OCT-based CFD simulation(Up to 2 years after the procedure)
- Time averaged wall shear stress obtained from OCT-based CFD simulation(Up to 2 years after the procedure)
- Presence of artefacts in OCT scan(Immediately following the procedure)
- Segmented vessel lumen based on CTA scan(Up to 2 years after the procedure)
- Segmented vessel lumen based on OCT scan(Up to 2 years after the procedure)
- Late luminal loss(Up to 2 years after the procedure)
- Correlation between late luminal loss and CTA-based CFD(Up to 2 years after the procedure)
- Correlation between late luminal loss and OCT-based CFD(Up to 2 years after the procedure)