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

Recruiting N/A Interventional Study
Cardiac Surgery Ischemia Limb
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Device Feasibility
Participants needed
15 (estimated)
Sponsor
IPERF SAS · Industry
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About This Trial
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 r…
Trial Locations
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Eligibility 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 o…
Contacts

Fabien Doguet, Surgeon

+33(0)1 60 13 60 89

dogufa76@gmail.com

CONTACT