Non Randomised, Prospective, Single Center Clinical Study to Evaluate the Safety and Procedural Feasibility of an Innovative Flow Assist Device, Pleioflow-RF.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Feasibility of the Pleioflow-RF device
研究概览
简要总结
The "Pleiades" study is a non randomised, prospective, single center clinical trial that aims to evaluate the safety and the procedural feasibility of an innovative flow assist device (Pleioflow-RF) in adult patients undergoing elective cardiac surgery.
详细描述
This is a non randomised, prospective, single center clinical study that aims to evaluate the safety and the procedural feasibility of an innovative flow assist device (Pleioflow-RF) in adult patients, undergoing elective cardiac surgery. The Pleioflow-RF is a percutaneous flow assist device that functions in combination with the traditional Intra Aortic Balloon (IAB). It represents a modified, probably improved, safer and more potent version of the latter, with respect to its dramatic ability to increase renal perfusion in low flow and pressure conditions -as displayed in large animal trials.
The Pleioflow RF -IAB assembly integrates two critical elements:
(i) a soft Nitinol stent element, positioned at the tip of the IAB, deployed in the descending Aorta that centralizes the IAB, thus preventing excessive IAB movement, protecting the wall of the Aorta from IAB induced injury, and the renal arteries from occlusion, (ii) a downstream valve, mounted within the above stent, that keeps the pressure and flow augmentation, created by the IAB's periodic inflation, localised below said valve, in the abdominal Aorta, where the renal arteries originate.
The device is used intraoepratively, during Cardiopulmonary by pass (CPB). During IAB inflation, the IAB occupies space and the pressure increases instantly. The downstream valve above the IAB, receives this pressure wave and closes. The valve closure blocks upstream flow, and diverts all the flow and pressure wave generated by the IAB primarily towards the kidneys and the periphery.
Due to the continuous IAB's perdiodic inflation and deflation, the device converts the constant CPB flow and pressure to pulsatile, towards the kidneys.
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
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and ≤ 85, men and women
- •Elective coronary artery bypass grafting surgery and/or heart valve surgery with planned CPB.
- •Written informed consent provided
- •Haemoglobulin (Hb) ≥ 11 g/dl in women and ≥ 12 g/dl for men
- •Ejection fraction ≥ 30%
- •Score≥ 3 according to the Cleveland Clinic Foundation risk factor scale for AKI and / or Chronic Kidney Disease (CKD) with preoperative glomerular filtration rate, estimated glomerular filtration rate, eGFR ≤50 ml / min / 1.7, 3 m2) as estimated by the equation of four Modified Diet and Renal Disease variables (MDRD type)
排除标准
- •emergency surgery
- •severe sepsis or rhabdomyolysis
- •severe preoperative renal insufficiency requiring renal replacement therapy (RRT) or even once RRT
- •receiving within the last 10 days nephrotoxic medications, such as radiocontrast material (> 100 ml), amphotericin B, aminoglycosides, NSAID, or trimethoprim-sulfamethoxazole with at least moderate renal impairment (eGFR ≤45)
- •Any severe coagulopathy
- •Participation in another trial
- •Any surgical or medical condition which according to investigator's opinion could create problem in the assessment of safety and /or efficacy of the device
- •Severe comorbidity with life expectancy < 6 months
- •History of poor compliance with previous treatment and incapability of giving informed consent
- •Pregnant or breastfeeding women. Pregnancy, confirmed by a positive laboratory test for Human Chorionic Gonadotropin, is considered from the time after conception until the end of the pregnancy.
- •Peripheral artery disease making insertion of IABP unfeasible
- •Preoperative intra-aortic balloon pump (IABP)
- •Preoperative other device in the same anatomical area (which could possibly create dysfunction of any of the other two devices)
研究组 & 干预措施
Subjects receiving the Pleioflow-RF device
Subjects receiving the Pleioflow-RF device in conjunction with IABP
干预措施: Pleioflow-RF (Device)
结局指标
主要结局
Feasibility of the Pleioflow-RF device
时间窗: Through end of Device removal procedure
Feasibility: Initiation and maintenance the Mean of the maxima (maximum values) of pulsatile pressure ≥65mmHg during cardiopulmonary bypass (CPB)
Safety of the Pleioflow-RF device
时间窗: Through end of Device removal procedure
Safety: Major Device-Related Adverse Events
次要结局
- Duration of Intensive Care Unit/Intensive Therapy Unit (ICU/ITU) stay(30 days)
- Duration of Hospital Stay(Up to 30 days postoperative)
- Acute Kidney injury (AKI)(Up to 7 days postopoerative)
- Intraoperative and Postoperative use of inotropes and vasopressors(Up to 7 days postoperative)
- Device- related adverse events(30 days)
- Levels of biomarkers.(Up to 7 days)
- Need for renal replacement therapy(Up to 7 days)
- Conversion of non- pulsatile to pulsatile flow and pressure during CPB(Up to 4 hours)
- Incidence of Pleioflow-RF Device's dysfunction and failures(Through end of Device removal procedure)
- 30-Day All-Cause Mortality(30 days)
- Evaluation of clinical data.(Up to 4 hours)
- Mean of Maximum pulsatile pressure values peripherally to the valve of the Pleiofow-RF device(Up to 4 hours)
- Measure of ease of device insertion delivery, deployment, positioning(At time of device insertion)
- Measure of ease of device removal(Through end of Device removal procedure)