Safety of the IPERF Femoral Arterial Cannula in Patients Undergoing Planned Cardiac Surgery With Extracorporeal Circulation Via Femoral Approach (FIH IPERF-01)

IPERF SAS

Status: Not yet enrolling

Conditions: Cardiac Surgery; Ischemia Limb

Treatments: Device: Cardiac surgery

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT07163234

IPERF-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Group 1

Experimental group

Description:

Single arm

Treatment:

Device: Cardiac surgery