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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05462223




Registration number
NCT05462223
Ethics application status
Date submitted
8/07/2022
Date registered
18/07/2022
Date last updated
13/03/2024

Titles & IDs
Public title
Alucent Vessel Restoration System for AVF
Scientific 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
Secondary ID [1] 0 0
1061-003
Universal Trial Number (UTN)
Trial acronym
Activate AVF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
AV Fistula 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Combination Product - Alucent Vessel Restoration System for AVF

Experimental: Alucent VRS for Treatment of Atherosclerotic Lesions - 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


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
Intervention code [1] 0 0
Combination Product
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
AVF Maturation
Timepoint [1] 0 0
2 weeks to 3 months

Eligibility
Key inclusion criteria
- 18 years of age and can provide informed consent

- Use birth control

- Chronic Kidney Disease
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Receiving hemodialysis

- Pregnant, breastfeeding, planning to become pregnant

- Receiving immunosuppressants

- Has "Long COVID"

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/07/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/12/2024
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Prince of Wales - Randwick
Recruitment hospital [3] 0 0
Royal North Shore Hospital & North Shore Private - Saint Leonards
Recruitment hospital [4] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [5] 0 0
Flinders Medical Center - Bedford Park
Recruitment hospital [6] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [7] 0 0
Northern Health - Richmond
Recruitment hospital [8] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
5042 - Bedford Park
Recruitment postcode(s) [6] 0 0
3004 - Melbourne
Recruitment postcode(s) [7] 0 0
3121 - Richmond
Recruitment postcode(s) [8] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
Poland
State/province [1] 0 0
Lublin
Country [2] 0 0
Poland
State/province [2] 0 0
Warsaw
Country [3] 0 0
Poland
State/province [3] 0 0
Wroclaw
Country [4] 0 0
Poland
State/province [4] 0 0
Zielona Góra

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Alucent Biomedical
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Feasibility of the Vessel Restoration System for AVF
Trial website
https://clinicaltrials.gov/ct2/show/NCT05462223
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kate Ecklund, MPH
Address 0 0
Country 0 0
Phone 0 0
3857722300
Fax 0 0
Email 0 0
kecklund@alucentbiomedical.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05462223