Elective Cardiac SurgeryNCT05662501
Pleiades Safety and Feasibility Study
A study testing Pleioflow-RF in people with Elective Cardiac Surgery, run by Pleioflow at 1 site in Greece.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Elective Cardiac Surgery
- What is being tested?
- Pleioflow-RF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- 10 Jan 2024to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 13Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Onassis Cardiac Center
Athens, 17674
Georgios Stavridis, +302109493314, gstavridis@ocsc.gr
Georgios Stavridis
About this study
Official title: 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.
Read the 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.
- Conditions
- Elective Cardiac Surgery
- Being tested
- Pleioflow-RF
- Keywords
- acute kidney injury, cardiac surgery, flow assist, intra-aortic balloon pump, renal failure
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pleioflow-RFDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Subjects receiving the Pleioflow-RF device | Experimental | Subjects receiving the Pleioflow-RF device in conjunction with IABP Receives: Device: Pleioflow-RF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Through end of Device removal procedure
Safety of the Pleioflow-RF device
Safety: Major Device-Related Adverse Events
Measured: Through end of Device removal procedure
Secondary outcomes (14)
Duration of Intensive Care Unit/Intensive Therapy Unit (ICU/ITU) stay
Measured: 30 days
Duration of Hospital Stay
Measured: Up to 30 days postoperative
Acute Kidney injury (AKI)
Measured: Up to 7 days postopoerative
Need for renal replacement therapy
Measured: Up to 7 days
Intraoperative and Postoperative use of inotropes and vasopressors
Number of days and dose of inotropes and vasopressors
Measured: Up to 7 days postoperative
30-Day All-Cause Mortality
Measured: 30 days
Device- related adverse events
Measured: 30 days
Evaluation of clinical data.
Recording the haemodynamic data: arterial pressure above and below the device
Measured: Up to 4 hours
Levels of biomarkers.
Recording the following biomarkers levels: Creatinine, Urea, electrolytes and Neutrophil gelatinase associated lipocalin (NGAL)
Measured: Up to 7 days
Conversion of non- pulsatile to pulsatile flow and pressure during CPB
Measured: 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
Measured: Up to 4 hours
Incidence of Pleioflow-RF Device's dysfunction and failures
Measured: 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.
Measured: 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
Measured: Through end of Device removal procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start10 Jan 2024
- Primary completion30 May 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pleioflow
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Georgios Stavridis, Principal investigator, Onassis Cardiac Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05662501
- Sponsor's protocol ID
- PLEIO21
- Status last verified
- Jan 2024
- First submitted
- 18 Jun 2022
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Randomised, Prospective, Single Center Clinical Study to Evaluate the Safety and Procedural Feasibility of an Innovative Flow Assist Device, Pleioflow-RF.
- ClinicalTrials.gov ID
- NCT05662501
- Acronym / sponsor ID
- PLEIO21
- Conditions
- Elective Cardiac Surgery
- Keywords
- acute kidney injury, cardiac surgery, flow assist, intra-aortic balloon pump, renal failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- PleioflowIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 22 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects receiving the Pleioflow-RF device | Experimental | Device: Pleioflow-RFSubjects receiving the Pleioflow-RF device in conjunction with IABP |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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%
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pleioflow-RFSubjects 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. | Device | Subjects receiving the Pleioflow-RF device |
Primary outcome
Feasibility of the Pleioflow-RF device
Time frame: 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
Time frame: Through end of Device removal procedure
Safety: Major Device-Related Adverse Events
14 secondary outcomes
Duration of Intensive Care Unit/Intensive Therapy Unit (ICU/ITU) stay
Time frame: 30 days
Duration of Hospital Stay
Time frame: Up to 30 days postoperative
Acute Kidney injury (AKI)
Time frame: Up to 7 days postopoerative
Need for renal replacement therapy
Time frame: Up to 7 days
Intraoperative and Postoperative use of inotropes and vasopressors
Time frame: Up to 7 days postoperative
30-Day All-Cause Mortality
Time frame: 30 days
Device- related adverse events
Time frame: 30 days
Evaluation of clinical data.
Time frame: Up to 4 hours
Levels of biomarkers.
Time frame: Up to 7 days
Conversion of non- pulsatile to pulsatile flow and pressure during CPB
Time frame: Up to 4 hours
Mean of Maximum pulsatile pressure values peripherally to the valve of the Pleiofow-RF device
Time frame: Up to 4 hours
Incidence of Pleioflow-RF Device's dysfunction and failures
Time frame: Through end of Device removal procedure
Measure of ease of device insertion delivery, deployment, positioning
Time frame: At time of device insertion
Measure of ease of device removal
Time frame: Through end of Device removal procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georgios Stavridis principal investigator
Onassis Cardiac Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pleioflow-RF in people with Elective Cardiac Surgery, run by Pleioflow at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aikaterini Dimitriou (+302106209866, Katerina_Dimitriou@pleioflow.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the Pleioflow-RF device (time frame: Through end of Device removal procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.