Cardiac Surgery, Ischemia Limb
Conditions
Keywords
Ischemia, Cardiac Surgery
Brief summary
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.
Detailed description
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.
Interventions
DEVICECardiac surgery
cardiac surgery
Sponsors
IPERF SAS
European Cardiovascular Research Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of the novel IPERF femoral arterial cannula | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with at least one ischemic event from cannula installation to decannulation | From enrollment to 30-60 days post surgery | 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. | From enrollment to 30-60 days post surgery | 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 | From enrollment to 30-60 days post surgery | 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) |
Countries
France
Contacts
CONTACTFabien Doguet, Surgeon
STUDY_DIRECTORPierre Mordant, Surgeon
Outcome results
None listed