Status:
NOT_YET_RECRUITING
Safety of the IPERF Femoral Arterial Cannula in Patients Undergoing Planned Cardiac Surgery With Extracorporeal Circulation Via Femoral Approach
Lead Sponsor:
IPERF SAS
Collaborating Sponsors:
European Cardiovascular Research Center
Conditions:
Cardiac Surgery
Ischemia Limb
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 extracorp...
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 extracorp...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT07163234
Start Date
November 1 2025
End Date
June 1 2026
Last Update
September 9 2025
Active Locations (1)
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1
Hôpital privé Jacques Cartier - Ramsay Santé
Massy, France, 91300