Alucent Vessel Restoration System for AVF

AV Fistula Clinical Trial

— Activate AVF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05462223
• Other study ID #: 1061-003
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2022
• Est. completion date: December 15, 2024

Study information

• Verified date: March 2024
• Source: Alucent Biomedical
• Contact: Kate Ecklund, MPH
• Phone: 3857722300
• Email: kecklund[@]alucentbiomedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Feasibility of the Vessel Restoration System for AVF

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 15, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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"

Related Conditions & MeSH terms

• AV Fistula
• Fistula

Intervention

Combination Product:
• Alucent Vessel Restoration System for AVF
Alucent Vessel Restoration System for AVF (VRS-AVF) consists of the following components: VRS 10-8-10 Dimer Coated Balloon Catheter for AVF VRS Light Fiber VRS Light Source

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Flinders Medical Center	Bedford Park	South Australia
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	Royal Perth Hospital	Perth	Western Australia
Australia	Prince of Wales	Randwick	New South Wales
Australia	Northern Health	Richmond	Victoria
Australia	Royal North Shore Hospital & North Shore Private	Saint Leonards	New South Wales
Poland	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

Sponsors (1)

Lead Sponsor	Collaborator
Alucent Biomedical

Countries where clinical trial is conducted

Australia,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AVF Maturation	Unassisted AVF Maturation using a fistulagram and needle sticks to assess maturation at specific time points	2 weeks to 3 months