Safety of the IPERF Femoral Arterial Cannula in Patients Undergoing Planned Cardiac Surgery With Extracorporeal Circulation Via Femoral Approach
Recruiting
N/A
Interventional Study
Cardiac Surgery
Ischemia Limb
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Device Feasibility
- Participants needed
- 15 (estimated)
- Sponsor
- IPERF SAS · Industry
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About This Trial
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 r…
Trial Locations
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Eligibility 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 o…
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