Renal Assist Device (RAD) for Patients With Renal Insufficiency Undergoing Cardiac Surgery

Last updated: January 22, 2024
Sponsor: 3ive Labs
Overall Status: Completed

Phase

N/A

Condition

Nephropathy

Kidney Disease

Kidney Failure (Pediatric)

Treatment

JuxtaFlow System

Clinical Study ID

NCT05990660
RAD1117-01
  • Ages 22-85
  • All Genders

Study Summary

The study is a prospective, non-randomized early feasibility study intended to evaluate the safety and performance of the JuxtaFlow System (also known as the JuxtaFlow Renal Assist Device (RAD)) in participants with pre-existing renal insufficiency who are undergoing cardiac surgery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Candidate cardiac surgical patients
  2. Elective or Urgent on-pump coronary artery bypass grafting (CABG) and/or valvularsurgery
  3. Age 22 to 85 years
  4. eGFR < 60 mL/min/1.73m2
  5. Signed informed consent

Exclusion

Exclusion Criteria:

  1. End-stage renal disease (receiving hemodialysis or glomerular filtration rate <15ml/min/1.73m2)
  2. Planned off-pump surgery
  3. Any patients with high-grade proteinuria (i.e., urine protein concentration > 300mg/dL)
  4. Pregnancy
  5. Any secondary condition as determined by the investigator that would place the subjectat an increased risk, or preclude the subject's full compliance with the studyprocedures, including injuries to the urinary organs and/or external genitals
  6. Current or planned treatment with an investigational drug (IND), device (IDE), orother investigational intervention within 3 months prior to or during participation inthis clinical trial

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: JuxtaFlow System
Phase:
Study Start date:
September 28, 2023
Estimated Completion Date:
January 18, 2024

Study Description

The BIPASS-AKI study is intended to evaluate participants who are at an increased risk of developing cardiac surgery-associated acute kidney injury (CSA-AKI), and, subsequently, overall poor outcomes. Patients to be considered for participation include those undergoing elective or urgent in-house on-pump cardiac surgery (to include coronary artery bypass graft, valvular surgery, or combination) and have pre-existing renal insufficiency as defined by a pre-operative eGFR between 15-60 mL/min. Participants meeting inclusion and exclusion criteria will be enrolled into a treatment arm (single-arm study) following the completion of informed consent. Participants will receive implantation of the JuxtaFlow Catheters following completion of the their cardiac surgery while remaining under anesthesia. Treatment with the JuxtaFlow System will be initiated upon the participant's arrival into the intensive care unit and continue for up to 24 hours post-operatively. Preoperative, intra-operative, and post-operative data will be collected on participants to include 15- and 30-day follow-up periods.

Connect with a study center

  • Polsko-Amerykanskie Kliniki Serca, Centrum Kardiologii

    Kraków, Bielsko-Biata 43-316
    Poland

    Site Not Available

  • Institute for Cardiovascular Diseases "Dedinje"

    Belgrade,
    Serbia

    Site Not Available

  • Institute of Cardiovascular Diseases of Vojvodina

    Sremska Kamenica,
    Serbia

    Site Not Available

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