Comparing a Suture-based System for the Removal of Arterial and Veinous ECMO Cannulas to the Stan… (NCT07019662) | Clinical Trial Compass
RecruitingNot Applicable
Comparing a Suture-based System for the Removal of Arterial and Veinous ECMO Cannulas to the Standard Approach
Germany102 participantsStarted 2025-10-27
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of a combined vessel-orientated clinical endpoint (VOCE)
Timeframe: within 48 hours post ECMO removal
Trial details
NCT IDNCT07019662
SponsorIHF GmbH - Institut für Herzinfarktforschung