Suture-based removal of femoral ECMO cannulas versus standard closure
Comparing a Suture-based System for the Removal of Arterial and Veinous ECMO Cannulas to the Standard Approach
This study tests whether a suture-based device (Perclose ProStyle) can close groin arteries and veins after VA-ECMO more safely or effectively than surgical closure or manual compression in adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IHF GmbH - Institut für Herzinfarktforschung Academic / other |
| Locations | 2 sites (Frankfurt and 1 other locations) |
| Trial ID | NCT07019662 on ClinicalTrials.gov |
What this trial studies
Adults on peripheral, percutaneous femoral VA-ECMO with arterial puncture above the femoral bifurcation are enrolled and randomized or assigned to decannulation using a suture-based vascular closure device (Perclose ProStyle) versus standard options of surgical closure or manual compression. Cannula sizes must be within the device's licensed outer diameter limits and initial cannulation must have been performed under ultrasound guidance. The study tracks immediate and short-term vascular outcomes such as bleeding, vessel injury, need for surgical repair, thrombosis, and other decannulation-related complications. Procedures take place at participating university cardiology centers in Germany under protocol-defined follow-up.
Who should consider this trial
Good fit: Adults (≥18) with peripheral percutaneous femoral VA-ECMO placed above the femoral bifurcation, with cannula sizes within the Perclose ProStyle limits and documented ultrasound-guided puncture, who are judged eligible for either the device or standard closure methods.
Not a fit: Patients with severe femoral artery calcification, ongoing local infection, surgical cannulation, or cannula sizes or anatomies outside the device's Instructions for Use are unlikely to benefit from the suture-based approach in this protocol.
Why it matters
Potential benefit: If successful, the suture-based approach could reduce bleeding and vessel complications and speed recovery after ECMO decannulation.
How similar studies have performed: Vascular closure devices have shown success for large-bore femoral access in other procedures (e.g., TAVR), but their use specifically for ECMO decannulation is less well studied.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Frankfurt and 1 other locations
- Universitäres Herz- und Gefäßzentrum Frankfurt ZIM - Med. Clinic 3 - Cardiology and Angiology — Frankfurt, Germany (Recruiting)
- Universitätsmedizin der Johannes Gutenberg-Universität Mainz - Zentrum für Kardiologie — Mainz, Germany (Recruiting)
Study contacts
- Principal investigator: Robert Stöhr, PD Dr. Dr. — Universitäres Herz- und Gefäßzentrum Frankfurt ZIM - Med. Clinic 3 - Cardiology and Angiology
- Study coordinator: Jelena Weller
- Email: close-ecmo@ihf.de
- Phone: +49 62159577216
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.