Eurosets arterial and venous cannulas for cardiopulmonary bypass procedures
A Two Phases Clinical Investigation Consisting of a Pre-Market, Pilot, Interventional, Not Randomized, Monocentric Investigation to Evaluate the Safety of PVC Arterial Cannula and PVC Venous Cannula (Class III Medical Devices) Intended to be Used During Cardiopulmonary Bypass (CPB) Procedure Followed by a Pre-Market, Pivotal, Interventional, Randomized, Non- Inferiority, Monocentric Investigation to Confirm the Safety and Evaluate the Performance of the Same Cannulas
This trial will test Eurosets arterial and venous cannulas during cardiopulmonary bypass in adults having elective coronary or aortic valve surgery to see if they are as safe and work as well as Medtronic cannulas.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Eurosets S.r.l. Industry-sponsored |
| Locations | 1 site (Bari, BA) |
| Trial ID | NCT07354841 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults (≥18 years) weighing 60–120 kg with a body surface area of 1.5–2.5 m2 who are scheduled for elective central cannulation for isolated coronary and/or aortic valve surgery and can give informed consent.
Not a fit: Patients undergoing emergency or repeat cardiac surgery, those with diabetes, hematologic disorders or thrombophilia, active malignancy, pregnancy, significant pulmonary or neurologic injury, immunosuppression, or outside the weight/BSA limits would be ineligible and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the Eurosets cannulas could offer a safe alternative to existing cannulas, increasing device options for surgeons and hospitals.
How similar studies have performed: While Medtronic cannulas are well-established in practice, published clinical data specific to Eurosets cannulas are limited, so this head-to-head pre-market comparison provides new device-specific evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bari, BA
- Anthea Hospital GVM Care & Research — Bari, Ba, Italy (Recruiting)
Study contacts
- Study coordinator: Prof. Giuseppe Nasso
- Email: gnasso@libero.it
- Phone: +39 080 5644111
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.