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

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.

NCT Number	NCT07163234
Lead Sponsor	IPERF SAS Collaborators: European Cardiovascular Research Center
Conditions	Cardiac Surgery, Ischemia Limb
Enrollment	15 participants
Start Date	2026-02-11
Primary Completion	2026-06 (estimated)
Study Completion	2026-08 (estimated)
Updated on ClinicalTrials.gov	2026-02-27