Actively Recruiting
Safety of the IPERF Femoral Arterial Cannula in Patients Undergoing Planned Cardiac Surgery With Extracorporeal Circulation Via Femoral Approach
Led by IPERF SAS · Updated on 2026-02-27
15
Participants Needed
2
Research Sites
24 weeks
Total Duration
On this page
Sponsors
I
IPERF SAS
Lead Sponsor
E
European Cardiovascular Research Center
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Safety of the IPERF Femoral Arterial Cannula in Patients Undergoing Planned Cardiac Surgery With Extracorporeal Circulation Via Femoral Approach
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Patient weighing less than 45 kg
- Patient weighing 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Hôpital privé Jacques Cartier - Ramsay Santé
Massy, France, 91300
Not Yet Recruiting
2
Hopital Jacques Cartier - Ramsay Santé
Massy, France
Actively Recruiting
Research Team
F
Fabien Doguet, Surgeon
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here