iPerf dual‑lumen femoral arterial cannula for leg perfusion during femoral‑access cardiac surgery
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 study will test whether the iPerf dual‑lumen femoral cannula can safely maintain blood flow to the leg during planned cardiac surgery using femoral extracorporeal circulation in adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Iperf Sas Industry-sponsored |
| Locations | 2 sites (Massy and 1 other locations) |
| Trial ID | NCT07163234 on ClinicalTrials.gov |
What this trial studies
This first‑in‑human, prospective, single‑arm phase I study will enroll 15 adult patients undergoing planned cardiac surgery with femoral extracorporeal circulation for up to 6 hours. The iPerf device is a dual‑lumen arterial cannula designed to provide both systemic and lower limb perfusion during femoral cannulation. Primary outcomes are procedure‑related and late adverse events up to 30 days after surgery, and secondary endpoints include ischemic events, tissue oxygen saturation measurements, and surgeon satisfaction with device handling. The trial is conducted at a single center in Massy, France, to demonstrate feasibility and safety of the device.
Who should consider this trial
Good fit: Adults aged 18 or older scheduled for planned cardiac surgery requiring femoral extracorporeal circulation for up to 6 hours who meet vessel size and weight criteria and can give informed consent.
Not a fit: Patients with very small common femoral arteries (≤6 mm), significant aorto‑iliac/femoral stenosis, prior iliac/femoral vascular surgery, extreme body weight (<45 kg or >130 kg), pregnancy, or participation in another interventional study are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the iPerf cannula could reduce the risk of acute limb ischemia by maintaining lower limb perfusion during femoral arterial cannulation.
How similar studies have performed: This is a first‑in‑human trial for the iPerf cannula; while other limb‑perfusion techniques are used clinically, the iPerf dual‑lumen design has not been previously tested in humans.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Massy and 1 other locations
- Hôpital privé Jacques Cartier - Ramsay Santé — Massy, France (Not_yet_recruiting)
- Hopital Jacques Cartier - Ramsay Santé — Massy, France (Recruiting)
Study contacts
- Study coordinator: Fabien Doguet, Surgeon
- Email: dogufa76@gmail.com
- Phone: +33(0)1 60 13 60 89
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.