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

Plain Language Summary

Simplified for easier understanding

This study is testing a new device called the Alucent Vessel Restoration System to help prepare blood vessels for creating an arteriovenous fistula (AVF) — a surgically connected artery and vein that is used as the access point for hemodialysis. Researchers want to see if this device improves fistula formation and function in people with chronic kidney disease before they need to start dialysis. **You may be eligible if...** - You are 18 or older with chronic kidney disease (CKD) - You are not yet on hemodialysis - You are planning for future dialysis access - You are willing to use effective birth control if applicable **You may NOT be eligible if...** - You are currently receiving hemodialysis - You are pregnant, breastfeeding, or planning to become pregnant during the study - You are taking immunosuppressant medications - You have "Long COVID" Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Adelaide Hospital

Adelaide, South Australia, Australia

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

Flinders Medical Center

Bedford Park, South Australia, Australia

Northern Health

Richmond, Victoria, Australia

Poznan University of Medical Sciences

Lublin, Poland

Lower Silesia Center of Heart Diseases MEDINet

Wroclaw, Poland

Klincznny Oddzial Chirurgii Naczyniowej Szpital Uniweryzstecki w Zielonej

Zielona Góra, Poland

Wojskowy Instytut Medczny z Centrainym Szpitalem Klinicznym Ministerstwa Obrony Narodowej

Warsaw, Poland

The Alfred Hospital

Melbourne, Victoria, Australia

Royal Perth Hospital

Perth, Western Australia, Australia

View Full Details on ClinicalTrials.gov

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NCT05462223


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