Cardiac SurgeryFIH IPERF-01NCT07163234
Safety of the IPERF Femoral Arterial Cannula in Patients Undergoing Planned Cardiac Surgery With Extracorporeal Circulation Via Femoral Approach
A study testing Cardiac surgery in people with Cardiac Surgery and Ischemia Limb, run by IPERF SAS at 2 sites in France.
Trial 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 extracorporeal circulation (ECC) via a femoral approach for up to 6 hours. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery, Ischemia Limb
- What is being tested?
- Cardiac surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesFrance
- Study dates
- 11 Feb 2026to 19 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital privé Jacques Cartier - Ramsay Santé
Massy, 91300
Hopital Jacques Cartier - Ramsay Santé
Massy
About this study
Official title: First-In-Human Study (Phase I) Evaluating the Safety of the IPERF Femoral Arterial Cannula in Patients Undergoing a Planned Cardiac Surgery Requiring the Use of an Extracorporeal Circulation Via a Femoral Approach for a Maximum of 6 Hours
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.
Read the 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 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
- Cardiac Surgery, Ischemia Limb
- Being tested
- Cardiac surgery
- Keywords
- Ischemia, Cardiac Surgery
- Medical subject headings
- Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac surgeryDevice
cardiac surgery
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Single arm Receives: Device: Cardiac surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the novel IPERF femoral arterial cannula
Per procedure and late adverse events related to the IPERF Femoral Arterial Cannula, up to 30 days after surgery.
Measured: From enrollment to 30-60 days post surgery
Secondary outcomes (3)
Number of patients with at least one ischemic event from cannula installation to decannulation
Number of patients with at least one clinical ischemic event from cannula installation to decannulation defined by clinical observations of the cannulated limb: paleness/ bluish appearance of the leg, oedema, coldness and increased skin recolouring time.
Measured: From enrollment to 30-60 days post surgery
Evolution of Tissue Oxygen Saturation (StO2) versus baseline during femoral cannulation with IPerf™ device between the cannulated and the non-cannulated lower limb.
Evolution of Tissue Oxygen Saturation (StO2) versus baseline the cannulated and non cannulated limb (Ceulemans Heart and Vessels, 2023 and versus baseline during femoral cannulation with IPerf™ device in the cannulated and non-cannulated lower limb by NIRS method
Measured: From enrollment to 30-60 days post surgery
Satisfaction of the surgeon
Satisfaction of the surgeon regarding insertion, positioning, stability, and withdrawal of the device: satisfaction score ≥3 (satisfaction scale: 1- Very dissatisfied, 2- Dissatisfied, 3-Neither dissatisfied or satisfied, 4- Satisfied, 5- Very satisfied)
Measured: From enrollment to 30-60 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start11 Feb 2026
- Primary completion19 Jun 2026
- Study completion19 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- IPERF SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Cardiovascular Research Center
- Responsible party
- Sponsor
- Investigators
- Pierre Mordant, Surgeon, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07163234
- Sponsor's protocol ID
- IPERF-01
- Acronym
- FIH IPERF-01
- Status last verified
- Nov 2026
- First submitted
- 27 Aug 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-In-Human Study (Phase I) Evaluating the Safety of the IPERF Femoral Arterial Cannula in Patients Undergoing a Planned Cardiac Surgery Requiring the Use of an Extracorporeal Circulation Via a Femoral Approach for a Maximum of 6 Hours
- ClinicalTrials.gov ID
- NCT07163234
- Acronym / sponsor ID
- FIH IPERF-01 / IPERF-01
- Conditions
- Cardiac Surgery, Ischemia Limb
- Keywords
- Ischemia, Cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- IPERF SASIndustry (pharma, biotech, devices)
- Collaborators
- European Cardiovascular Research Center
- Study start
- 11 Feb 2026 (actual)
- Primary completion
- 19 Jun 2026 (actual)
- Study completion
- 19 Jun 2026 (actual)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Cardiac surgerySingle arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac surgerycardiac surgery | Device | Group 1 |
Primary outcome
Safety of the novel IPERF femoral arterial cannula
Time frame: From enrollment to 30-60 days post surgery
Per procedure and late adverse events related to the IPERF Femoral Arterial Cannula, up to 30 days after surgery.
3 secondary outcomes
Number of patients with at least one ischemic event from cannula installation to decannulation
Time frame: From enrollment to 30-60 days post surgery
Evolution of Tissue Oxygen Saturation (StO2) versus baseline during femoral cannulation with IPerf™ device between the cannulated and the non-cannulated lower limb.
Time frame: From enrollment to 30-60 days post surgery
Satisfaction of the surgeon
Time frame: From enrollment to 30-60 days post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Mordant, Surgeon study director
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac surgery in people with Cardiac Surgery and Ischemia Limb, run by IPERF SAS at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the novel IPERF femoral arterial cannula (time frame: From enrollment to 30-60 days post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.