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Comparing a Suture-based System for the Removal of Arterial and Veinous ECMO Cannulas to the Standard Approach

NCT07019662 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2026-04-16

No results posted yet for this study

Summary

Background:

Patients with severe heart and lung failure may be treated with VA-ECMO (veno-arterial extracorporeal membrane oxygenation), a life-support machine that temporarily takes over the function of the heart and lungs. To connect the patient to ECMO, large tubes (cannulas) are inserted into major blood vessels in the groin area.

When the patient no longer needs ECMO, these cannulas must be removed - a process known as decannulation. Closing the artery after removing the cannula is a critical step and can be associated with complications such as bleeding, vessel injury, or blood clots.

Currently, there are different methods to close the artery:

* Surgical closure: open surgery to directly suture the artery
* Manual compression: pressing on the artery to stop bleeding
* Vascular closure devices (VCDs): special tools that close the artery through the skin

There is no clear standard yet on which method is safest and most effective for ECMO patients.

Purpose of the Study:

The study aims to determine whether using a vascular closure device is as safe and effective as the current standard methods for femoral artery closure after VA-ECMO.

Study Design:

This is a randomized controlled trial. Patients who are scheduled for decannulation after VA-ECMO support will be randomly assigned to one of two groups:

* Intervention Group: Patients receive a vascular closure device to seal the artery (Abbott Perclose™ ProStyle™ Suture-Mediated Closure System).
* Control Group: Patients receive standard care, which may be either:

* Manual compression, or
* Surgical closure, depending on the treating physician's judgment and the patient's condition.

This allows for a real-world comparison of the Closure Device method to current clinical practice.

Conditions

  • VA-ECMO

Interventions

DEVICE

Decannulation with a medical device

Wound Closure with a medical device

PROCEDURE

Decannulation using surgical removal or manual compression

Wound closure using surgical removal or manual compression

Sponsors & Collaborators

  • IHF GmbH - Institut für Herzinfarktforschung

    lead OTHER

Principal Investigators

  • Robert Stöhr, PD Dr. Dr. · Universitäres Herz- und Gefäßzentrum Frankfurt ZIM - Med. Clinic 3 - Cardiology and Angiology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-27
Primary Completion
2027-02-28
Completion
2027-09-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07019662 on ClinicalTrials.gov