Pleiades Safety and Feasibility Study

Non Randomised, Prospective, Single Center Clinical Study to Evaluate the Safety and Procedural Feasibility of an Innovative Flow Assist Device, Pleioflow-RF.

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.

Study Overview

• Status: Recruiting
• Conditions: Elective Cardiac Surgery
• Intervention / Treatment: Device: Pleioflow-RF

Detailed Description

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.

The device is expected to increase substantially the renal perfusion during Cardiac Surgery; it may therefore decrease the post-operative incidence of renal failure.

The hypothesis of this clinical study is that the placement of the Pleioflow-RF intraoperatively, particularly in patients who are more prone to developing renal deterioration based on either their Cleveland Clinic prognostic score, or/and the pre-existence of renal impairment, can prevent further renal deterioration in these patients. These vulnerable patients comprise 10-20% of the total cardiac surgery population.

Following informed consent, subjects eligible for a elective cardiac surgery that meet all of the inclusion, and none of the exclusion, criteria will be enrolled into the study. The Pleioflow-RF will be inserted preferrably through a 9F sheath into the femoral artery; then advanced into the descending thoracic aorta, and positioned below the origin of the left subclavian artery under transoesophageal echocardiography guidance. Subsequently through the same sheath, the intra-aortic balloon (IAB) will be placed and be advanced up to the proximal tip end of the Pleioflow-RF device. The IABP will be connected to an IAB pump. The duration of operation of the assembly (Pleioflow-RF and the IAB) will be for as long as the cardiopulmonary bypass(CPB) time, in order to protect the kidneys from hypoperfusion, during that time. After the end of the CPB, the IABP and the device will be removed. Subjects will be followed up until 30 days post intervention.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aikaterini Dimitriou; Phone Number: +302106209866; Email: Katerina_Dimitriou@pleioflow.com

Study Locations

• Greece
  • Athens, Greece, 17674
    • Recruiting
    • Onassis Cardiac Center
    • Contact: Georgios Stavridis; Phone Number: +302109493314; Email: gstavridis@ocsc.gr
    • Principal Investigator: Georgios Stavridis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 and ≤ 85, men and women
2. Elective coronary artery bypass grafting surgery and/or heart valve surgery with planned CPB.
3. Written informed consent provided
4. Haemoglobulin (Hb) ≥ 11 g/dl in women and ≥ 12 g/dl for men
5. Ejection fraction ≥ 30%
6. 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)

Exclusion Criteria:

1. emergency surgery
2. severe sepsis or rhabdomyolysis
3. severe preoperative renal insufficiency requiring renal replacement therapy (RRT) or even once RRT
4. 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)
5. Any severe coagulopathy
6. Participation in another trial
7. 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
8. Severe comorbidity with life expectancy < 6 months
9. History of poor compliance with previous treatment and incapability of giving informed consent
10. 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.
11. Peripheral artery disease making insertion of IABP unfeasible
12. Preoperative intra-aortic balloon pump (IABP)
13. Preoperative other device in the same anatomical area (which could possibly create dysfunction of any of the other two devices)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subjects receiving the Pleioflow-RF device; Subjects receiving the Pleioflow-RF device in conjunction with IABP	Device: Pleioflow-RF; Subjects who are going to undergo scheduled cardiac surgery and are prone to developing renal insufficiency, will receive the Pleioflow-RF device in conjunction with IABP during CPB. Subjects will be followed until 30-days post-intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the Pleioflow-RF device	Feasibility: Initiation and maintenance the Mean of the maxima (maximum values) of pulsatile pressure ≥65mmHg during cardiopulmonary bypass (CPB)	Through end of Device removal procedure
Safety of the Pleioflow-RF device	Safety: Major Device-Related Adverse Events	Through end of Device removal procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Need for renal replacement therapy		Up to 7 days
Intraoperative and Postoperative use of inotropes and vasopressors	Number of days and dose of inotropes and vasopressors	Up to 7 days postoperative
30-Day All-Cause Mortality		30 days
Device- related adverse events		30 days
Evaluation of clinical data.	Recording the haemodynamic data: arterial pressure above and below the device	Up to 4 hours
Levels of biomarkers.	Recording the following biomarkers levels: Creatinine, Urea, electrolytes and Neutrophil gelatinase associated lipocalin (NGAL)	Up to 7 days
Conversion of non- pulsatile to pulsatile flow and pressure during CPB		Up to 4 hours
Mean of Maximum pulsatile pressure values peripherally to the valve of the Pleiofow-RF device	Mean of Maximum pulsatile pressure values peripherally to the valve of the Pleiofow-RF device, greater than or equal to 80 mmHg (≥ 80 mm Hg), or increase of Mean of maxima (maximum values of pulsatile pressure), peripherally to the valve of the Pleiofow-RF device≥ 20 mmHg above the mean arterial pressure (MAP) of the non pulsatile flow of the extracorporeal circulation, the latter being recorded 2 minutes prior to the activation of the device	Up to 4 hours
Incidence of Pleioflow-RF Device's dysfunction and failures		Through end of Device removal procedure
Measure of ease of device insertion delivery, deployment, positioning	Each assessment (insertion, delivery, deployment, and positioning) will be measured independently using the same unit according to the Procedure feasibility score scale as described in the Appendix 1 in the Protocol. A scale (Procedure feasibility score scale as described in the Appendix 1 in the Protocol) will be used to assess the aforementioned outcome. Minimum value is 1 and maximum value is 5, with higher scores stating a better outcome.	At time of device insertion
Measure of ease of device removal	A scale (Procedure feasibility score scale as described in Appendix 1 in the Protocol) will be used to assess the aforementioned outcome. Minimum value is 1 and maximum value is 5, with higher scores stating a better outcome	Through end of Device removal procedure

Collaborators and Investigators

• Sponsor: Pleioflow
• Investigators: Principal Investigator: Georgios Stavridis, Onassis Cardiac Center

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2024
• Primary Completion (Estimated): May 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: June 18, 2022
• First Submitted That Met QC Criteria: December 14, 2022
• First Posted (Actual): December 22, 2022

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: cardiac surgery; acute kidney injury; renal failure; intra-aortic balloon pump; flow assist
• Other Study ID Numbers: PLEIO21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No