New device aims to prevent leg damage during heart surgery
NCT ID NCT07163234
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage study tests a new tube (cannula) placed in the leg artery during heart surgery that uses a heart-lung machine. The device is designed to keep blood flowing to the leg, reducing the risk of limb damage. Fifteen adults having planned heart surgery will be enrolled, and the main goal is to check safety over 30 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- IPERF femoral arterial cannula (a dual-lumen device for lower limb perfusion during heart surgery)
- What this could lead to
- If it works, this could lead to a safer way to do heart surgery that uses leg arteries, reducing the risk of leg complications.
- What could go wrong
- This is a very early, small study (15 people) testing only safety and feasibility. The device may not work as hoped, and unexpected side effects could occur.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hopital Jacques Cartier - Ramsay Santé
RECRUITINGMassy, France
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Hôpital privé Jacques Cartier - Ramsay Santé
NOT_YET_RECRUITINGMassy, 91300, France
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Other studies related to the condition(s) this trial covers.
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