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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Cardiac surgery
  cardiac surgery

Первичные конечные точки

• Safety of the novel IPERF femoral arterial cannula [Срок оценки: From enrollment to 30-60 days post surgery]

Вторичные конечные точки (3)

• Number of patients with at least one ischemic event from cannula installation to decannulation [Срок оценки: 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. [Срок оценки: From enrollment to 30-60 days post surgery]
• Satisfaction of the surgeon [Срок оценки: From enrollment to 30-60 days post surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Оценка устройства

Центры проведения

Франция · 2 центра

• Hôpital privé Jacques Cartier - Ramsay Santé — Massy
• Hopital Jacques Cartier - Ramsay Santé — Massy

Идентификаторы

NCT: NCT07163234 · IPERF-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗