RecruitingNot ApplicableNCT05462223

Alucent Vessel Restoration System for AVF

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


Sponsor

Alucent Biomedical

Enrollment

30 participants

Start Date

Jul 15, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Feasibility of the Vessel Restoration System for AVF


Eligibility

Min Age: 18 Years

Inclusion Criteria3

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

Exclusion Criteria4

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

Interventions

COMBINATION_PRODUCTAlucent 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


Locations(12)

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Prince of Wales

Randwick, New South Wales, Australia

Royal North Shore Hospital & North Shore Private

Saint Leonards, New South Wales, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Flinders Medical Center

Bedford Park, South Australia, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Northern Health

Richmond, Victoria, Australia

Royal Perth Hospital

Perth, Western Australia, Australia

Poznan University of Medical Sciences

Lublin, Poland

Wojskowy Instytut Medczny z Centrainym Szpitalem Klinicznym Ministerstwa Obrony Narodowej

Warsaw, Poland

Lower Silesia Center of Heart Diseases MEDINet

Wroclaw, Poland

Klincznny Oddzial Chirurgii Naczyniowej Szpital Uniweryzstecki w Zielonej

Zielona Góra, Poland

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05462223