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

NCT ID: NCT07019662

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-27
• Study Completion Date: 2027-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Decannulation using the Perclose™ ProStyle™

Group Type: EXPERIMENTAL

Decannulation with a medical device

Intervention Type: DEVICE

Wound Closure with a medical device

Standard of Care: Decannulation using surgical removal or manual compression

Group Type: ACTIVE_COMPARATOR

Decannulation using surgical removal or manual compression

Intervention Type: PROCEDURE

Wound closure using surgical removal or manual compression

Interventions

Decannulation with a medical device

Wound Closure with a medical device

Intervention Type: DEVICE

Decannulation using surgical removal or manual compression

Wound closure using surgical removal or manual compression

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 Years
• Femoral placement of VA-ECMO with peripheral, percutaneous cannulation
• Arterial puncture site above the femoral bifurcation
• Cannula size must match or be smaller than the maximally licensed diameter for Perclose™ ProStyle™ (26 F (French) outer diameter arterial and 29 F outer diameter veinous)
• Patients must be eligible for either the Perclose™ ProStyle™ device or one of the two guideline-compliant alternatives for ECMO cannula removal (manual compression or surgical closure) according to the investigator's judgment.
• Initial arterial and/or venous puncture for ECMO cannulation was performed using ultrasound guidance with corresponding documentation available in the patient record.

Exclusion Criteria

• Severe calcification
• Surgical cannulation
• Ongoing Infection of the ECMO site
• Any patient who does not fullfil the eligibility criteria for the use of the study device according to its current Instructions for Use (IFU), including known contraindications, limitations or warnings.
• Participation in another interventional clinical trial.
• Patients who are pregnant (assessed by clinical routine testing) or lactating.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IHF GmbH - Institut für Herzinfarktforschung

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Stöhr, PD Dr. Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitäre Herz- und Gefäßzentrum Frankfurt ZIM - Med. Clinic 3 - Cardiology and Angiology

Locations

Universitäre Herz- und Gefäßzentrum Frankfurt ZIM - Med. Clinic 3 - Cardiology and Angiology

Frankfurt, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Jelena Weller

Role: CONTACT

close-ecmo@ihf.de

+49 62159577216

Marcel Kunadt, Dr.

Role: CONTACT

Other Identifiers

MDR-004

Identifier Type: -

Identifier Source: org_study_id