First-In-Human Study (Phase I) Evaluating the Safety of the IPERF Femoral Arterial Cannula in Patients Undergoing a Planned Cardiac Surgery Requiring the Use of an Extracorporeal Circulation Via a Femoral Approach for a Maximum of 6 Hours
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Safety of the novel IPERF femoral arterial cannula
研究概览
简要总结
This is a first-in-human, prospective, single-arm, phase I clinical study evaluating the safety of the iPerf femoral arterial cannula in patients undergoing planned cardiac surgery requiring extracorporeal circulation (ECC) via a femoral approach for up to 6 hours. The iPerf device is a dual-lumen arterial cannula designed to provide systemic and lower limb perfusion during ECC, with the goal of reducing the risk of acute limb ischemia. The study will be conducted at a single center in France and will include 15 adult patients. Primary outcomes focus on procedure-related and late adverse events up to 30 days post-surgery. Secondary objectives include assessment of ischemic events, tissue oxygen saturation, and surgeon satisfaction with device handling. The study aims to demonstrate feasibility and safety of the iPerf cannula as an innovative solution for lower limb perfusion during femoral artery cannulation.
详细描述
This is a first-in-human, prospective, single-arm, phase I clinical study evaluating the safety of the iPerf femoral arterial cannula in patients undergoing planned cardiac surgery requiring extracorporeal circulation (ECC) via a femoral approach for up to 6 hours. The iPerf device is a dual-lumen arterial cannula designed to provide systemic and lower limb perfusion during ECC, with the goal of reducing the risk of acute limb ischemia. The study will be conducted at a single center in France and will include 15 adult patients. Primary outcomes focus on procedure-related and late adverse events up to 30 days post-surgery. Secondary objectives include assessment of ischemic events, tissue oxygen saturation, and surgeon satisfaction with device handling. The study aims to demonstrate feasibility and safety of the iPerf cannula as an innovative solution for lower limb perfusion during femoral artery cannulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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 aged 18 years or older
- •Patient able to understand the study procedures, provide written informed consent, and comply with study procedures
- •Patients with planned cardiac surgery requiring the use of an extracorporeal circulation via a femoral approach for a maximum of 6 hours.
- •Patient affiliated to the social security system
排除标准
- •Patient weighting less than 45 kg
- •Patient weighting more than 130 kg
- •Patient with common femoral artery diameter less or equal to 6 mm
- •Patient with a stenosis of the aorta, iliac artery, or femoral artery reducing their diameter of more than 50%
- •Patient with previous vascular or endovascular surgery of the iliac or femoral arteries
- •Patient participating in another interventional study
- •Patients with known arterial dissection
- •Patient who is pregnant at the time of enrollment
- •Patients under judicial protection, guardianship or curatorship or subjects deprived of their liberty by judicial or administrative decision
研究组 & 干预措施
Group 1
Single arm
干预措施: Cardiac surgery (Device)
结局指标
主要结局
Safety of the novel IPERF femoral arterial cannula
时间窗: From enrollment to 30-60 days post surgery
Per procedure and late adverse events related to the IPERF Femoral Arterial Cannula, up to 30 days after surgery.
次要结局
- Number of patients with at least one ischemic event from cannula installation to decannulation(From enrollment to 30-60 days post surgery)
- Evolution of Tissue Oxygen Saturation (StO2) versus baseline during femoral cannulation with IPerf™ device between the cannulated and the non-cannulated lower limb.(From enrollment to 30-60 days post surgery)
- Satisfaction of the surgeon(From enrollment to 30-60 days post surgery)