Comparison of Lower Limb Endovascular Interventions With and Without the EndoNaut Workstation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Therenva
- 入组人数
- 200
- 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
To demonstrate that the use of EndoNaut for endovascular procedures on the femoropopliteal axis has a clinical impact for the patient (decrease in irradiation and the volume of contrast product) as well as for nursing staff (reduction in irradiation) compared to procedures performed without EndoNaut.
详细描述
Peripheral artery disease (PAD) is characterized by a narrowing of the size of arteries, which resulting in a loss of hemodynamic load. Endovascular (or percutaneous) procedures performed at the infrainguinal level (axefemoro-popliteal) are very common in affected patients. Therenva offers a complete and consistent lightweight navigation solution (EndoNaut®) based on artificial intelligence (AI) algorithms, and providing technology accessible to all operating rooms for PAD procedures. The aim of this study is to demonstrate that the use of EndoNaut for endovascular procedures on the femoropopliteal axis has a clinical impact for the patient (decrease in irradiation and the volume of contrast product) as well as for nursing staff (reduction in irradiation) compared to the procedures performed by EndoNaut.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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.
结局指标
主要结局
Volume of contrast product used during the routine care procedure (ml)
时间窗: 1 day At enrollment
Volume are reported in mL
Irradiation parameters: dose-area quantification (mGy/m2)
时间窗: 1 day At enrollment
Parameter given by the X-ray imaging device
Irradiation parameters: evaluation of the Fluoroscopy duration (min)
时间窗: 1 day At enrollment
Parameter given by the X-ray imaging device
Irradiation parameters: measurement of air Kerma (mGy)
时间窗: 1 day At enrollment
Parameter given by the X-ray imaging device
次要结局
未报告次要终点