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.
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
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%
Single group
Cardiac surgery
Devicecardiac surgery
Safety of the novel IPERF femoral arterial cannula
Per procedure and late adverse events related to the IPERF Femoral Arterial Cannula, up to 30 days after surgery.
Number of patients with at least one ischemic event from cannula installation to decannulation
Number of patients with at least one clinical ischemic event from cannula installation to decannulation defined by clinical observations of the cannulated limb: paleness/ bluish appearance of the leg, oedema, coldness and increased skin recolouring time.
Evolution of Tissue Oxygen Saturation (StO2) versus baseline during femoral cannulation with IPerf™ device between the cannulated and the non-cannulated lower limb.
Evolution of Tissue Oxygen Saturation (StO2) versus baseline the cannulated and non cannulated limb (Ceulemans Heart and Vessels, 2023 and versus baseline during femoral cannulation with IPerf™ device in the cannulated and non-cannulated lower limb by NIRS method
Satisfaction of the surgeon
Satisfaction of the surgeon regarding insertion, positioning, stability, and withdrawal of the device: satisfaction score ≥3 (satisfaction scale: 1- Very dissatisfied, 2- Dissatisfied, 3-Neither dissatisfied or satisfied, 4- Satisfied, 5- Very satisfied)
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IPERF SAS
Lead sponsor
European Cardiovascular Research Center
Collaborator
