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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2026-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Stenting of the Superficial Femoral and/or Proximal Popliteal Artery Project

NCT01820637

Atherosclerosis of Native Arteries of the Extremities

COMPLETED NA

Promus PREMIER Below The Knee Registry

NCT05054764

Peripheral Arterial Disease Arterial Disease Arterial Disease of Legs

UNKNOWN

PMCF Study for Peripheral Arteries Below the Knee (BTK)

NCT05444660

Peripheral Artery Disease

COMPLETED

Comparison of the PrimAry Long Versus Short Coverage With Drug-Eluting Stents for Long FemoRopopliteal Artery DiseasE (PARADE II): Investigator-initiated Clinical Study

NCT02701881

Femoropopliteal Artery Disease

UNKNOWN PHASE4

A Post-market Registry of the MARIS-stent (Invatec) Implanted in the Superficial Femoral Artery

NCT01067885

Peripheral Artery Disease

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiac Surgery Ischemia Limb

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

Single arm

Group Type EXPERIMENTAL

Cardiac surgery

Intervention Type DEVICE

cardiac surgery

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cardiac surgery

cardiac surgery

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No