Innova Breeze®-Based Roadmap for Peripheral Arterial Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Amount of iodinated contrast volume
研究概览
简要总结
Over the past decade, interventional endovascular treatment, whenever feasible, has become the first line management in the treatment of lower extremity arterial disease (LEAD) for many indications. Growth of endovascular therapy was based on shorter hospital length of stay and lower complications rates. This minimally invasive procedure allows the revascularization of the lower limbs under fluoroscopy guidance, with injection of iodinated contrast allowing to analyze the arteries. However, many of these patients present renal insufficiency which could be worsened due to the iodinated contrast injections during the endovascular procedure for LEAD. Consequently, the vascular interventionalist should find a way to achieve patient revascularization while minimizing iodinated contrast injections in order to maintain the renal function.
The aim of this study is to compare the amount of iodine contrast used during LEAD endovascular revascularization with and without the Innova Breeze® and blended roadmap software.
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
- None
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 ≥ 18 years
- •Patient has a history of symptomatic peripheral arterial disease (Rutherford classification 2-6)
- •Patients with indication of femoropopliteal revascularization according the European guidelines (1)
- •Patient agrees to undergo all protocol required follow-up examinations and requirements at the investigational site
- •French-speaking patient
- •Patient is affiliated to the Social Security or equivalent system
- •Patients is able and willing to give free, informed and express oral consent
- •Iliac and/or below the knee lesions are allowed in combination to femoropopliteal lesions
排除标准
- •Upper limb approach
- •Femoral antegrade approach
- •Pregnant or breastfeeding woman
- •Adult under guardianship or trusteeship
- •Iodinated contrast allergy
- •Reduction in estimated Glomerular Filtration Ratio (eGFR) ≤ 29 ml/min/m2 (11)
- •Patients included in other studies which interact with intraoperative imaging protocols
- •Concurrent participation in an interventional (drug or device) study for which the follow-up period is not complete.
- •Patient under tutorship or curatorship
- •Patient deprived of liberty
结局指标
主要结局
Amount of iodinated contrast volume
时间窗: Day 1
This outcome corresponds to the volume of iodinated contrast used at the end of the procedure.
次要结局
- Estimation of renal function at 1 month(Month 1)
- Patient safety in terms of radiation exposure at the end of the procedure(Day 1)
- Staff safety in terms of radiation exposure at the end of the procedure(Day 1)
- Patient clinical improvement(Month 1)
- Estimation of renal function post-operative(Day 4)