NCT04434586招募中不适用
Contribution of Optical Coherence Tomography in the Endovascular Treatment of Femoral Occlusions
University Hospital, Lille2 个研究点 分布在 1 个国家目标入组 166 人开始时间: 2020年6月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 166
- 试验地点
- 2
- 主要终点
- Primary patency rate at 1 year.
研究概览
简要总结
This is a common care study. A study for evaluating the quality of balloon inflation and stent application will be performed in 2D angiography alone in the control group and then by 2D and OCT angiography for the experimental group. The benefit could be an improvement in the results of revascularization of femoropopliteal lesions thanks to OCT which allows a 3D visualization of the arterial lumen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Patient over 18 years old
- •Femoral-popliteal lesion TASC-C or TASC-D de novo (F1 to P1)
- •Starting lesion on the superficial femoral artery and not extending beyond the intercondylar notch (P2)
- •≥1 continuous permeable leg axis directly injecting the plantar arch
- •Rutherford 2-5
排除标准
- •Patient under personal protection regime (tutorship, guardianship)
- •Absence of arterial axis in permeable leg
- •Patient presenting a limb acute ischaemia (chart evolving since less than 14 days)
- •Patient without favorable element to consider healing
- •History of stents on the femoropopliteal axis
- •History of femoropopliteal bypass
- •Untreated stenosis ≥30% on the iliac axis and common femoral upstream
- •Popliteal lesion beyond the intercondylar notch (P2)
结局指标
主要结局
Primary patency rate at 1 year.
时间窗: at 12 months (+/- 2months)
The permeability rate is defined by the echodoppler criteria: PVS\>2.4m/s or appearance of stenosis on the previously treated segment \>70%.
次要结局
- Target vessel revascularisation(at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months))
- Primary patency rate at 1 year.(at 1month (+/- 10days), 6months (+/- 1month))
- Target lesion revascularisation(at 1month (+/- 10days), 6months (+/- 1month) and 12 months (+/- 2months))
- cost-effectiveness analyses(at 12 months (+/- 2months))
研究者
研究点 (2)
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