Safety of the IPERF Femoral Arterial Cannula in Patients Undergoing Planned Cardiac Surgery With Extracorporeal Circulation Via Femoral Approach

NCT07163234 | Recruiting DMC

• 1 other identifier: IPERF-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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 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

Keywords

Ischemia; Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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.

  From enrollment to 30-60 days post surgery

• Satisfaction of the surgeon

  From enrollment to 30-60 days post surgery

Study Arms (1)

Group 1

EXPERIMENTAL

Single arm

Device: Cardiac surgery

Interventions

Cardiac surgery DEVICE

cardiac surgery

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IPERF SAS: lead
• European Cardiovascular Research Center: collaborator

Study Sites (2)

Hôpital privé Jacques Cartier - Ramsay Santé

Massy, 91300, France

NOT YET RECRUITING

Hopital Jacques Cartier - Ramsay Santé

Massy, France

RECRUITING

MeSH Terms

Conditions

Ischemia

Interventions

Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Pierre Mordant, Surgeon

  STUDY DIRECTOR

Central Study Contacts

Fabien Doguet, Surgeon

CONTACT

+33(0)1 60 13 60 89; dogufa76@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 9, 2025
• Study Start: February 11, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)