Eurosets arterial and venous cannulas for cardiopulmonary bypass procedures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a two-phase, monocentric clinical program performed at a single hospital in Bari, Italy. Phase 1 is a pre-market pilot, non-randomized investigation focused on initial safety of the Eurosets PVC arterial and venous cannulas used during cardiopulmonary bypass. Phase 2 is a randomized, pivotal non-inferiority trial comparing Eurosets cannulas to commercially available Medtronic cannulas to confirm safety and performance. The study enrolls adults scheduled for elective central cannulation during isolated coronary and/or aortic valve surgery with specified weight and body surface area limits.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patient is considered able and willing to provide written informed consent according to the ethically approved informed consent form;
2. Female and male patients aged ≥ 18;
3. Body weight between 60 and 120 kg;
4. Body surface area (BSA) between 1.5 and 2.5 m2;
5. Patients scheduled to undergo central cannulation for cardiopulmonary bypass (CPB) in elective surgery procedures (isolated coronary and/or aortic valve surgery).

Exclusion Criteria:

1. Emergency cases;
2. Re-do cardiac surgery procedure;
3. Diabetes mellitus;
4. Hematologic diseases or history of thrombophilia;
5. Pregnancy or breastfeeding;
6. Concomitant major cardiac procedures;
7. Active malignant/metastatic neoplasm of any type;
8. Presence of pneumothorax and/or pulmonary emphysema;
9. Significant central nervous system injury;
10. Current intracranial hemorrhage;
11. Immunosuppression;
12. Contraindication for therapeutic anticoagulation (e.g., heparin);
13. Anatomical and structural abnormalities which, in the opinion of the Investigator, may interfere with the participation to the study;
14. Abnormal or pathological cannulation site;
15. Uncontrolled active bleeding;
16. Awaiting transplantation;
17. Requiring preoperative extracorporeal membrane oxygenation;
18. Presence of any relevant severe condition or clinically relevant abnormal laboratory parameters that in the opinion of the Investigator may interfere with the participation to the study.
19. Patient is taking part in another interventional clinical study;
20. Patient is not able to understand the nature of this study or is unwilling or unable to attend the EOS Visit.

Where it's running

• Anthea Hospital GVM Care & Research
  Bari, Ba, Italy Recruiting

Study contacts

• Study coordinator: Prof. Giuseppe Nasso
• Email: gnasso@libero.it
• Phone: +39 080 5644111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.