[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620224":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":52,"collaborators":26,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":26,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":26,"enrollmentInfo":63,"targetDuration":26,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":80,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Eurosets S.r.l.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Eurosets Arterial and Venous Cannula","EXPERIMENTAL","Phase 1: All enrolled subjects will undergo cardiopulmonary bypass using the investigational Eurosets arterial and venous cannulas to evaluate the safety.\n\nPhase 2: Participants will undergo cardiopulmonary bypass using the investigational Eurosets arterial and venous cannulas to confirm safety and to evaluate the performance.",[13],"Device: Eurosets Venous and Arterial Cannula",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Arterial and Venous Cannula","ACTIVE_COMPARATOR","Phase 2: Participants will undergo cardiopulmonary bypass using commercially available arterial and venous cannulas currently used in standard clinical practice.",[19],"Device: Control Arterial and Venous Cannulas",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Eurosets Venous and Arterial Cannula","Phase 1: Use of investigational Eurosets arterial and venous cannulas during CPB to assess safety and preliminary performance.The Arterial cannulae are designed for insertion in the ascending Aorta. For this Investigation the arterial cannula is reinforced-long curved with flange tip, 3\u002F8\" connector with luer lock, 24 Fr.The Venous Cannulae are designed to be used for vena cava and right atrium blood drainage during CPB surgery. For this Investigation the venous cannula is dual stage without connector, lighthouse tip, 32\u002F40 Fr.\n\nPhase 2: Use of investigational PVC arterial and venous cannulas during cardiopulmonary bypass (CPB) to confirm safety and evaluate performance compared to control group. For Investigation device: same of phase 1. For Control Group: the Arterial Cannula is EOPA (Medtronic), 24 Fr; the Venous Cannula is Two stage MC2 (Medtronic), 32\u002F40 Fr.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Control Arterial and Venous Cannulas","Phase 2: Use of commercially available arterial and venous cannulas as comparator devices to evaluate the performance of the investigational PVC Arterial and Venous Cannulas during cardiopulmonary bypass (CPB) procedures. the control cannulas are EOPA 24Fr (Medtronic) as Arterial Cannula and Two Stage MC2 32\u002F40Fr (Medtronic) as Venous Cannula.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Prof. Giuseppe Nasso","CONTACT","+39 080 5644111","gnasso@libero.it",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":26},"Anthea Hospital GVM Care & Research","RECRUITING","Bari","BA","70124","Italy","IT",{"type":47,"coordinates":48},"Point",[49,50],16.86982,41.12066,{"lat":50,"lon":49},{"type":53,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100620224","safety-and-performance-evaluation-of-cpb-venous-and-arterial-cannulas-100620224",false,"NCT07354841","Safety and Performance Evaluation of CPB Venous and Arterial Cannulas","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","Inclusion Criteria:\n\n1. Patient is considered able and willing to provide written informed consent according to the ethically approved informed consent form;\n2. Female and male patients aged ≥ 18;\n3. Body weight between 60 and 120 kg;\n4. Body surface area (BSA) between 1.5 and 2.5 m2;\n5. Patients scheduled to undergo central cannulation for cardiopulmonary bypass (CPB) in elective surgery procedures (isolated coronary and\u002For aortic valve surgery).\n\nExclusion Criteria:\n\n1. Emergency cases;\n2. Re-do cardiac surgery procedure;\n3. Diabetes mellitus;\n4. Hematologic diseases or history of thrombophilia;\n5. Pregnancy or breastfeeding;\n6. Concomitant major cardiac procedures;\n7. Active malignant\u002Fmetastatic neoplasm of any type;\n8. Presence of pneumothorax and\u002For pulmonary emphysema;\n9. Significant central nervous system injury;\n10. Current intracranial hemorrhage;\n11. Immunosuppression;\n12. Contraindication for therapeutic anticoagulation (e.g., heparin);\n13. Anatomical and structural abnormalities which, in the opinion of the Investigator, may interfere with the participation to the study;\n14. Abnormal or pathological cannulation site;\n15. Uncontrolled active bleeding;\n16. Awaiting transplantation;\n17. Requiring preoperative extracorporeal membrane oxygenation;\n18. 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.\n19. Patient is taking part in another interventional clinical study;\n20. Patient is not able to understand the nature of this study or is unwilling or unable to attend the EOS Visit.","ALL","18 Years",{"count":64,"type":65},80,"ESTIMATED","INTERVENTIONAL",[68],"NA","This is a two-phase study evaluating the Eurosets arterial and venous cannulas for use during cardiopulmonary bypass (CPB) procedures. Phase 1 is a pilot study focused on assessing cannula safety. Phase 2 is a pivotal study aimed at confirming safety and evaluating efficacy through comparison with Medtronic cannulas (control group).\n\nThe results will be compared for non-inferiority with those obtained using the control group cannulas.",[71,72,73,74,75,76,77,78,79],"Cardiac Surgery","Heart Surgery","Cardiopulmonary Bypass","Coronary Surgery","Aortic Valve Surgery","Cannulation","Venous Cannulation","Arterial Cannulation","Coronary Surgery With Cardiopulmonary Bypass",[81,82,83,73,71,84,85,86,75,74,87,88,89,90,91,92,93,94],"Arterial Cannula","Venous Cannula","Extracorporeal Circulation","Medical Device","Device Safety","Device Performance","Two Phases clinical investigation","Monocentric Study","Two Phases Study","Serious Adverse Events (SAE)","CVP","NIRS","Venous Cannula Drainage Pressure","Arterial Cannula Reinfusion Pressure","2026-01-12",{"date":97,"type":98},"2026-01-21","ACTUAL",{"date":100,"type":98},"2025-10-21",{"date":102,"type":65},"2026-09-30",{"name":5,"class":6},1]