Pleiades Safety and Feasibility Study

NCT05662501 | Unknown DMC

• 1 other identifier: PLEIO21
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Elective Cardiac Surgery

Keywords

acute kidney injury; cardiac surgery; flow assist; intra-aortic balloon pump; renal failure

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• 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

  Up to 7 days postoperative

Study Arms (1)

Subjects receiving the Pleioflow-RF device

EXPERIMENTAL

Subjects receiving the Pleioflow-RF device in conjunction with IABP

Device: Pleioflow-RF

Interventions

Pleioflow-RF DEVICE

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.

Subjects receiving the Pleioflow-RF device

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pleioflow: lead

Study Sites (1)

Onassis Cardiac Center

Athens, 17674, Greece

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury; Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Georgios Stavridis

  Onassis Cardiac Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aikaterini Dimitriou

CONTACT

+302106209866; Katerina_Dimitriou@pleioflow.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2022
• First Posted: December 22, 2022
• Study Start: January 10, 2024
• Primary Completion: May 30, 2024
• Study Completion: September 30, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-01

Locations

GR (1)