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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Other interventions - 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:

1. VRS 10-8-10 Dimer Coated Balloon Catheter for AVF
2. VRS Light Fiber
3. VRS Light Source


Other interventions: Alucent 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

Intervention code [1] 0 0
Other interventions
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
Not applicable
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.