NCT07163234

Safety of the IPERF Femoral Arterial Cannula in Patients Undergoing Planned Cardiac Surgery With Extracorporeal Circulation Via Femoral Approach

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: IPERF SAS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiac Surgery
• Ischemia Limb

Interventions

Type	Name	Description
DEVICE	Cardiac surgery	cardiac surgery

Timeline

• Start date: 2026-02-11
• Primary completion: 2026-06-01
• Completion: 2026-08-01
• First posted: 2025-09-09
• Last updated: 2026-02-27

Locations

2 sites across 1 country: France