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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
研究概览
简要总结
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).
The results will be compared for non-inferiority with those obtained using the control group cannulas.
详细描述
The Clinical Investigation is 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.
The aim of these investigations are: 1) to evaluate safety of Eurosets Venous Cannula and Arterial Cannula in patients subjected to CPB and 2) to evaluate the performance and safety of Arterial Cannula and Venous Cannula intended to be used during CPB procedure. The results obtained will be compared by non-inferiority to the results obtained by Medtronic cannulae (control group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is considered able and willing to provide written informed consent according to the ethically approved informed consent form;
- •Female and male patients aged ≥ 18;
- •Body weight between 60 and 120 kg;
- •Body surface area (BSA) between 1.5 and 2.5 m2;
- •Patients scheduled to undergo central cannulation for cardiopulmonary bypass (CPB) in elective surgery procedures (isolated coronary and/or aortic valve surgery).
排除标准
- •Emergency cases;
- •Re-do cardiac surgery procedure;
- •Diabetes mellitus;
- •Hematologic diseases or history of thrombophilia;
- •Pregnancy or breastfeeding;
- •Concomitant major cardiac procedures;
- •Active malignant/metastatic neoplasm of any type;
- •Presence of pneumothorax and/or pulmonary emphysema;
- •Significant central nervous system injury;
- •Current intracranial hemorrhage;
- •Immunosuppression;
- •Contraindication for therapeutic anticoagulation (e.g., heparin);
- •Anatomical and structural abnormalities which, in the opinion of the Investigator, may interfere with the participation to the study;
- •Abnormal or pathological cannulation site;
- •Uncontrolled active bleeding;
- •Awaiting transplantation;
- •Requiring preoperative extracorporeal membrane oxygenation;
- •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.
- •Patient is taking part in another interventional clinical study;
- •Patient is not able to understand the nature of this study or is unwilling or unable to attend the EOS Visit.