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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05462223

Acronym

Activate AVF

Enrollment

Registered

2022-07-18

Start date

2022-07-15

Completion date

2024-12-15

Last updated

2024-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AV Fistula

Brief summary

Feasibility of the Vessel Restoration System for AVF

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

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

Study design

Allocation

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

A prospective, single-arm, multicenter, open-label study of the VRS-AVF for use as adjunctive therapy in the surgical creation of an end-to-side brachiocephalic (BC) AVF.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Australia, Poland

Contacts

Primary ContactKate Ecklund, MPH

kecklund@alucentbiomedical.com3857722300

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026