Safety and Effectiveness Evaluation of Novel MICS Venous Cannula
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Effectiveness: the mean pressure drop (mm Hg) to maintain the desired flow rate (L/min) during the standard surgical procedure
研究概览
简要总结
This is a prospective, open-label, single-arm, single-center clinical investigation designed to evaluate the safety and performance of a Novel Venous Cannula during on-pump cardiac surgery requiring transfemoral venous cannulation. The investigation aims to assess the pressure drop across the cannula during extracorporeal circulation and the incidence of serious adverse events associated with its use. A total of 42 participants will be enrolled.
详细描述
This clinical investigation evaluates a Novel Venous Cannula intended for drainage of venous blood during extracorporeal circulation in cardiac surgery. The cannula is made of polyurethane and includes a flexible metallic mesh that allows it to collapse during insertion and expand in situ. It is designed for single use, sterile, and is introduced using a dedicated insertion kit.
The study is a non-randomized, open-label, monocentric, single-arm investigation involving 42 adult patients undergoing elective cardiac surgery requiring transfemoral venous cannulation. The investigation includes three visits: a screening visit (from Day -7 to Day -1), the procedure day (Day 0), and a follow-up visit at Day 7 ± 3 days.
The primary effectiveness outcome is the mean pressure drop (mm Hg) across the cannula required to maintain the target flow rate during surgery. The primary safety outcome is the number of serious adverse events (SAEs) related to the use of the investigational device.
Secondary outcomes include several efficacy-related parameters (e.g., venous line flow, pump flow, cannula positioning, volume of infusion, cardioplegic solution usage, and others), as well as safety outcomes including mortality, cardiovascular events, and neurological complications at 7 days post-procedure.
There is no control group in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
Open-label
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
- •Age > 18 years
- •Informed consent obtained
- •Hospitalised patients undergoing transfemoral venous cannulation for on pump cardiac surgery procedure
排除标准
- •Active bleeding
- •Need of ECLS
- •Low platelet count (<150,000)
- •Any clinical conditions that contra-indicate the anti-coagulation
- •Any clinical condition that, in the opinion of the investigator, may interfere with the procedure
- •Subjects participating in any other clinical trial or investigation with a medical device within 3 months before Assessment visit
研究组 & 干预措施
Experimental Arm - Novel Self-expanding Venous Cannula
Participants in this arm will undergo transfemoral venous cannulation using the Novel Self-expanding Venous Cannula during on-pump cardiac surgery procedures. The investigational device is a single-use, sterile polyurethane cannula reinforced with a flexible metallic mesh that allows self-expansion once deployed into the vessel. The device is intended to facilitate efficient venous drainage as part of the extracorporeal circulation system. The study aims to evaluate the device's performance in terms of pressure drop and safety profile.
干预措施: Self-expanding Venous Cannula (Device)
结局指标
主要结局
Effectiveness: the mean pressure drop (mm Hg) to maintain the desired flow rate (L/min) during the standard surgical procedure
时间窗: During the surgical procedure (Day 0)
Measurement of the mean pressure drop (in millimeters of mercury, mmHg) across the novel venous cannula required to maintain the target blood flow rate (liters per minute) during cardiopulmonary bypass in cardiac surgery patients.
Safety: the number of SAE with the Novel Venous Cannula during the standard surgical procedure
时间窗: From Day 0 (procedure day) to 7 days post-procedure
Number of serious adverse events (SAEs) occurring during the surgical procedure that are related or possibly related to the use of the novel venous cannula, including device-related complications, cardiovascular events, and other procedure-associated serious adverse events.
次要结局
- Venous Line Flow During Extracorporeal Circulation Unit of Measure: mL/min(During the surgical procedure (Day 0))
- Mean pump flow during extracorporeal circulation Unit of Measure: L/min/m²(During the surgical procedure (Day 0))
- Number of cannulae in the surgical field during surgical procedure Unit of Measure: Count (number)(During the surgical procedure (Day 0))
- Number of cannula tip displacement as detected by TTE/TEE during surgical procedure Unit of Measure: n (%)(During the surgical procedure (Day 0))
- Mean increase in free Hb measure during surgical procedure Unit of Measure: mg/dL(During the surgical procedure (Day 0))
- Mean volume of infusion during surgical procedure Unit of Measure: mL(During the surgical procedure (Day 0))
- Mean volume of cardioplegic solution Unit of Measure: mL(During the surgical procedure (Day 0))
- Mean speed of aspirators during surgical procedure Unit of Measure: mL/min(During the surgical procedure (Day 0))
- Mean percentage of pump flow increase due to the patient's metabolic needs Unit of Measure: %(During the surgical procedure (Day 0))
- Mean volume of recovery blood re-administered during surgical procedure Unit of Measure: mL(During the surgical procedure (Day 0))
- Number of patients for whom blood concentrator was used Unit of Measure: Count (number of patients)(During the surgical procedure (Day 0))
- Presence of echocardiographic abnormalities Unit of Measure: n (%)(During the surgical procedure (Day 0))
- Number of correctly delivery and deployed Novel Venous Cannula Unit of Measure: Count (number of cannulae)(During the surgical procedure (Day 0))
- Number of technical success without procedural SAE Unit of Measure: n (%)(During the surgical procedure (Day 0))
- Number of deaths at 7 days after procedure Unit of Measure: Count (number of patients)(From Day 0 (procedure day) to 7 days post-procedure)
- Number of cardiovascular deaths at 7 days after procedure Unit of Measure: Count (number of patients)(From Day 0 (procedure day) to 7 days post-procedure)
- Number of cardiovascular SAEs at 7 days after procedure Unit of Measure: Count (number of patients)(From Day 0 (procedure day) to 7 days post-procedure)
- Number of stroke at 7 days after procedure Unit of Measure: Count (number of patients)(From Day 0 (procedure day) to 7 days post-procedure)
- Number minor neurological disorder at 7 days after procedure Unit of Measure: Count (number of patients)(From Day 0 (procedure day) to 7 days post-procedure)