Safety and Performance Evaluation of CPB Venous and Arterial Cannulas

Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

• Устройство 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, 3/8" 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 con
• Устройство 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 32/40Fr (Medtronic) as Venous Cannula.

Первичные конечные точки

• Phase 1: Safety of Eurosets Arterial and Venous Cannulas [Срок оценки: At Visit 1 (Pre and during surgical procedure), at Visit 2 (24 hours post-surgical procedure) and at Visit 3 (within 6-7 days post-surgical procedure)]
• Phase 2: Performance of Eurosets Arterial Cannulas [Срок оценки: Time points during CPB: 1st: pre-clamping/CPB initiation, 2nd: pre-weaning]
• Phase 2: Performance of Eurosets Venous Cannulas [Срок оценки: Time points during CPB: 1st: pre-clamping/CPB initiation (full flow), 2nd: 10 minutes post-clamping, 3rd: 30 minutes post-clamping.]

Вторичные конечные точки (12)

• Phase 1: Clinical Parameters collected for safety: pH [Срок оценки: At Visit 1. Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping, (pre) weaning/ decannulation.]
• Phase 1: Clinical Parameters collected for safety: pCO2 [Срок оценки: At Visit 1. Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping, (pre) weaning/ decannulation.]
• Phase 1: Clinical Parameters collected for safety: pO2 [Срок оценки: At Visit 1. Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping, (pre) weaning/ decannulation.]
• Phase 1: Clinical Parameters collected for safety: Blood Flow [Срок оценки: At Visit 1. Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping, (pre) weaning/ decannulation.]
• Phase 1: Clinical Parameters collected for safety: Mean arterial pressure (MAP) [Срок оценки: At Visit 1. Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping, (pre) weaning/ decannulation.]
• Phase 1: Clinical Parameters collected for safety: Mixed venous oxygen saturation (SvO2) [Срок оценки: At Visit 1. Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping, (pre) weaning/ decannulation.]
• Phase 1: Clinical Parameters collected for safety: Arterial oxygen saturation (SaO2) [Срок оценки: At Visit 1. Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping, (pre) weaning/ decannulation.]
• Phase 1: Clinical Parameters collected for safety: Vacuum level [Срок оценки: At Visit 1. Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping, (pre) weaning/ decannulation.]
• Phase 1: Vital sign collected for safety: body temperature [Срок оценки: At Visit 0 (from day -3 to day -1), Day of Surgery - Visit 1 (Day 0), Visit 2 (24 hours after surgery), Visit 3 (6-7 days after surgery), at Unscheduled Visit(s).]
• Phase 1: Vital sign collected for safety: Heart Rate [Срок оценки: At Visit 0 (from day -3 to day -1), Day of Surgery - Visit 1 (Day 0), Visit 2 (24 hours after surgery), Visit 3 (6-7 days after surgery).]
• Phase 1: Vital Sign collected for safety: Blood Flow [Срок оценки: At Visit 0 (from day -3 to day -1), Day of Surgery - Visit 1 (Day 0), Visit 2 (24 hours after surgery), Visit 3 (6-7 days after surgery).]
• Phase 1: Vital sign collected for safety: Diastolic pressure [Срок оценки: At Visit 0 (from day -3 to day -1), Day of Surgery - Visit 1 (Day 0), Visit 2 (24 hours after surgery), Visit 3 (6-7 days after surgery).]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Италия · 1 центр

• Anthea Hospital GVM Care & Research — Bari

Публикации

• Ismail A, Semien G, Sharma S, Collier SA, Miskolczi SY. Cardiopulmonary Bypass. 2024 Aug 12. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482190/ PMID 29489210
• von Segesser LK, Ferrari E, Delay D, Maunz O, Horisberger J, Tozzi P. Routine use of self-expanding venous cannulas for cardiopulmonary bypass: benefits and pitfalls in 100 consecutive cases. Eur J Cardiothorac Surg. 2008 Sep;34(3):635-40. doi: 10.1016/j.ejcts.2008.05.037. Epub 2008 Jul 16. PMID 18635371
• Sarkar M, Prabhu V. Basics of cardiopulmonary bypass. Indian J Anaesth. 2017 Sep;61(9):760-767. doi: 10.4103/ija.IJA_379_17. PMID 28970635
• Authors/Task Force Members; Kunst G, Milojevic M, Boer C, De Somer FMJJ, Gudbjartsson T, van den Goor J, Jones TJ, Lomivorotov V, Merkle F, Ranucci M, Puis L, Wahba A; EACTS/EACTA/EBCP Committee Reviewers; Alston P, Fitzgerald D, Nikolic A, Onorati F, Rasmussen BS, Svenmarker S. 2019 EACTS/EACTA/EBCP guidelines on cardiopulmonary bypass in adult cardiac surgery. Br J Anaesth. 2019 Dec;123(6):713-7 PMID 31585674
• Lamelas J, Aberle C, Macias AE, Alnajar A. Cannulation Strategies for Minimally Invasive Cardiac Surgery. Innovations (Phila). 2020 May/Jun;15(3):261-269. doi: 10.1177/1556984520911917. Epub 2020 May 21. PMID 32437215
• Narasaki S, Miyoshi H, Nakamura R, Sumii A, Watanabe T, Otsuki S, Tsutsumi YM. Venous cannula occlusion during cardiopulmonary bypass recognized by ultrasonography of the internal jugular vein. JA Clin Rep. 2022 Apr 12;8(1):29. doi: 10.1186/s40981-022-00519-2. PMID 35412158
• Wahba A, Milojevic M, Boer C, De Somer FMJJ, Gudbjartsson T, van den Goor J, Jones TJ, Lomivorotov V, Merkle F, Ranucci M, Kunst G, Puis L; EACTS/EACTA/EBCP Committee Reviewers. 2019 EACTS/EACTA/EBCP guidelines on cardiopulmonary bypass in adult cardiac surgery. Eur J Cardiothorac Surg. 2020 Feb 1;57(2):210-251. doi: 10.1093/ejcts/ezz267. No abstract available. PMID 31576396

Идентификаторы

NCT: NCT07354841 · DE-62-22 · CIV-IT-25-03-051856

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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