Alucent Vessel Restoration System for AVF
Activate 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
1 other identifier
interventional
30
2 countries
12
Brief Summary
Feasibility of the Vessel Restoration System for AVF
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2022
Typical duration for not_applicable
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2022
CompletedStudy Start
First participant enrolled
July 15, 2022
CompletedFirst Posted
Study publicly available on registry
July 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2024
CompletedMarch 13, 2024
March 1, 2024
1.8 years
July 8, 2022
March 12, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
AVF Maturation
Unassisted AVF Maturation using a fistulagram and needle sticks to assess maturation at specific time points
2 weeks to 3 months
Study Arms (1)
Alucent VRS for Treatment of Atherosclerotic Lesions
EXPERIMENTALAlucent 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
Interventions
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
Eligibility Criteria
You may qualify if:
- years of age and can provide informed consent
- Use birth control
- Chronic Kidney Disease
You may not qualify if:
- Receiving hemodialysis
- Pregnant, breastfeeding, planning to become pregnant
- Receiving immunosuppressants
- Has "Long COVID"
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
Prince of Wales
Randwick, New South Wales, 2031, Australia
Royal North Shore Hospital & North Shore Private
Saint Leonards, New South Wales, 2065, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
Flinders Medical Center
Bedford Park, South Australia, 5042, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Northern Health
Richmond, Victoria, 3121, Australia
Royal Perth Hospital
Perth, Western Australia, 6000, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2022
First Posted
July 18, 2022
Study Start
July 15, 2022
Primary Completion
May 15, 2024
Study Completion
December 15, 2024
Last Updated
March 13, 2024
Record last verified: 2024-03