Endovascular Procedures With Computer Assistance in the Chronic Occlusive Arthritis of the Lower Limbs on the Femoro-popliteal Stage.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Volume of contrast product used during the routine care procedure (ml)
研究概览
简要总结
Pilot study to assess the feasibility of creation of a bone and arterial panorama by 2D-2D registration technique during endovascular femoro-popliteal procedures with a mobile C-arm X-ray system using EndoNaut® software.
详细描述
The aim of this study is to show that it is possible to give a complete image of the area to be operated by the surgeon by creating a complete bone and arterial panorama of the femoro-popliteal axis with 2D-2D registration techniques. This study should have a clinical impact for the patient and caregiver. With this technique, we expect a reduction in the irradiation of the patient and the caregivers, a decrease in the volume of injected contrast product and a decrease in operating time.
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 with peripheral arterial disease of the lower limbs, all clinical stages, lesions of the femoro-popliteal stage and candidates for endovascular treatment of these lesions.
- •Major patients
- •Patients not opposed to their participation in the study
排除标准
- •Patients requiring conventional surgical revascularization.
- •Patient under legal protection (guardianship, safeguard of justice).
- •Pregnant or lactating women
结局指标
主要结局
Volume of contrast product used during the routine care procedure (ml)
时间窗: At the inclusion day
Volume are reported in mL
Irradiation parameters: evaluation of the Fluoroscopy duration (min)
时间窗: At the inclusion day
Parameter given by the X-ray imaging device
Irradiation parameters: dose-area quantification (mGy/m2)
时间窗: At inclusion
Parameter given by the X-ray imaging device
Quantification of the registration errors
时间窗: At the inclusion day
The 2D-2D registration is driven by an error index (intrinsic software criterion) given by the software at the end of the registration process
Irradiation parameters: measurement of air Kerma (mGy)
时间窗: At the inclusion day
Parameter given by the X-ray imaging device
Irradiation parameters: evaluation of the number of required angiograms
时间窗: At the inclusion day
Parameter given by the X-ray imaging device
Operating time (min)
时间窗: At the inclusion day
Delay between the beginning (patient anesthesia) and the end (patient transferred to post interventional care room) of the procedure
次要结局
未报告次要终点