Alucent Vessel Restoration System for AVF (Activate AVF)

March 12, 2024 updated by: Alucent Biomedical

A Study of the Safety and Feasibility of the Vessel Restoration System for AVF to Promote the Physiologic and Functional Maturation of Upper-extremity Autologous End-to-Side Arteriovenous Fistulas (AVF) in Patients With Chronic Kidney Disease: ACTIVATE AVF

Feasibility of the Vessel Restoration System for AVF

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A study of the safety and feasibility of the Vessel Restoration System for AVF to promote the physiologic and functional maturation of a Brachiocephalic End-to-Side Arteriovenous Fistulas (AVF) in Patients with Chronic Kidney Disease Stage V (Pre-dialysis): ACTIVATE AVF

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Recruiting
        • Royal Prince Alfred Hospital
        • Contact:
        • Principal Investigator:
          • Isuru Nammuni
      • Randwick, New South Wales, Australia, 2031
      • Saint Leonards, New South Wales, Australia, 2065
        • Recruiting
        • Royal North Shore Hospital & North Shore Private
        • Contact:
        • Principal Investigator:
          • Vikram Puttaswamy
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Royal Adelaide Hospital
        • Contact:
        • Principal Investigator:
          • Ewan Macaulay
      • Bedford Park, South Australia, Australia, 5042
        • Recruiting
        • Flinders Medical Center
        • Contact:
        • Principal Investigator:
          • Chris Delaney
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • The Alfred Hospital
        • Contact:
        • Principal Investigator:
          • Gerard Goh
      • Richmond, Victoria, Australia, 3121
        • Recruiting
        • Northern Health
        • Contact:
        • Principal Investigator:
          • Shrikkanth Ranjarajan
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Recruiting
        • Royal Perth Hospital
        • Contact:
        • Principal Investigator:
          • Biombe Mwipatayi
  • Poland
      • Lublin, Poland
        • Recruiting
        • Poznan University of Medical Sciences
      • Warsaw, Poland
        • Recruiting
        • Wojskowy Instytut Medczny z Centrainym Szpitalem Klinicznym Ministerstwa Obrony Narodowej
      • Wrocław, Poland
        • Recruiting
        • Lower Silesia Center of Heart Diseases MEDINet
      • Zielona Góra, Poland
        • Recruiting
        • Klincznny Oddzial Chirurgii Naczyniowej Szpital Uniweryzstecki w Zielonej

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years of age and can provide informed consent
  • Use birth control
  • Chronic Kidney Disease

Exclusion Criteria:

  • Receiving hemodialysis
  • Pregnant, breastfeeding, planning to become pregnant
  • Receiving immunosuppressants
  • Has "Long COVID"

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alucent VRS for Treatment of Atherosclerotic Lesions

Alucent Vessel Restoration System for AVF (VRS-AVF) consists of the following components:

  1. VRS 10-8-10 Dimer Coated Balloon Catheter for AVF
  2. VRS Light Fiber
  3. VRS Light Source
Combination product: Alucent Vessel Restoration System for AVF

Alucent Vessel Restoration System for AVF (VRS-AVF) consists of the following components:

  1. VRS 10-8-10 Dimer Coated Balloon Catheter for AVF
  2. VRS Light Fiber
  3. VRS Light Source

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AVF Maturation
Time Frame: 2 weeks to 3 months
Unassisted AVF Maturation using a fistulagram and needle sticks to assess maturation at specific time points
2 weeks to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alucent Biomedical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2022

Primary Completion (Estimated)

May 15, 2024

Study Completion (Estimated)

December 15, 2024

Study Registration Dates

First Submitted

July 8, 2022

First Submitted That Met QC Criteria

July 13, 2022

First Posted (Actual)

July 18, 2022

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1061-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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