AV FistulaActivate AVFNCT05462223
Alucent Vessel Restoration System for AVF
A study testing Alucent Vessel Restoration System for AVF in people with AV Fistula, run by Alucent Biomedical at 12 sites in 2 countries.
Trial summary
Feasibility of the Vessel Restoration System for AVF Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AV Fistula
- What is being tested?
- Alucent Vessel Restoration System for AVF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 15 Jul 2022to 15 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age and can provide informed consent
- Use birth control
- Chronic Kidney Disease
Who cannot join
- Receiving hemodialysis
- Pregnant, breastfeeding, planning to become pregnant
- Receiving immunosuppressants
- Has "Long COVID"
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
Australia8 sites, 8 recruiting
- Recruiting
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Bronwyn Hockley, 0870743077, Bronwyn.hockley@sa.gov.au
Ewan Macaulay
- Recruiting
Flinders Medical Center
Bedford Park, South Australia, 5042
Mel Toomey, 82045445, melanie.toomey@sa.gov.au
Chris Delaney
- Recruiting
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Lisa Turner, 0431025843, lisa.turner@health.nsw.gov.au
Isuru Nammuni
- Recruiting
The Alfred Hospital
Melbourne, Victoria, 3004
Helen Kavnoudias, 0390763606, h.kavnoudias@alfred.org.au
Gerard Goh
- Recruiting
Royal Perth Hospital
Perth, Western Australia, 6000
Jackie Wong, 0892240226, jackie@bibombe.com
Biombe Mwipatayi
- Recruiting
Prince of Wales
Randwick, New South Wales, 2031
Elena Matthews, 0433834022, pow.vascular.institute@gmail.com
Roman Varcoe
- Recruiting
Northern Health
Richmond, Victoria, 3121
Kira Edwards, 0422312452, kira.edwards@nh.org.au
Shrikkanth Ranjarajan
- Recruiting
Royal North Shore Hospital & North Shore Private
Saint Leonards, New South Wales, 2065
Linda Pallot, 0413883344, inda.pallot@health.nsw.gov.au
Vikram Puttaswamy
Poland4 sites, 4 recruiting
- Recruiting
Poznan University of Medical Sciences
Lublin
- Recruiting
Wojskowy Instytut Medczny z Centrainym Szpitalem Klinicznym Ministerstwa Obrony Narodowej
Warsaw
- Recruiting
Lower Silesia Center of Heart Diseases MEDINet
Wroclaw
- Recruiting
Klincznny Oddzial Chirurgii Naczyniowej Szpital Uniweryzstecki w Zielonej
Zielona Góra
About this study
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
Feasibility of the Vessel Restoration System for AVF
Read the 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
- Conditions
- AV Fistula
- Being tested
- Alucent Vessel Restoration System for AVF
- Medical subject headings
- Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alucent Vessel Restoration System for AVFCombination product
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
| Study group | Role | What they receive |
|---|---|---|
| Alucent VRS for Treatment of Atherosclerotic Lesions | Experimental | 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 Receives: Combination Product: Alucent Vessel Restoration System for AVF |
What is being measured
The primary outcome is the main question the study is designed to answer.
AVF Maturation
Unassisted AVF Maturation using a fistulagram and needle sticks to assess maturation at specific time points
Measured: 2 weeks to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start15 Jul 2022
- Primary completion15 May 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AV FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alucent Biomedical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462223
- Sponsor's protocol ID
- 1061-003
- Acronym
- Activate AVF
- Status last verified
- Mar 2024
- First submitted
- 8 Jul 2022
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05462223
- Acronym / sponsor ID
- Activate AVF / 1061-003
- Conditions
- AV Fistula
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Alucent BiomedicalIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 15 May 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 18 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Alucent VRS for Treatment of Atherosclerotic Lesions | Experimental | Combination Product: Alucent Vessel Restoration System for AVFAlucent 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age and can provide informed consent
- Use birth control
- Chronic Kidney Disease
Key exclusion criteria (4 listed)
- Receiving hemodialysis
- Pregnant, breastfeeding, planning to become pregnant
- Receiving immunosuppressants
- Has "Long COVID"
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alucent Vessel Restoration System for AVFAlucent 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 | Combination product | Alucent VRS for Treatment of Atherosclerotic Lesions |
Primary outcome
AVF Maturation
Time frame: 2 weeks to 3 months
Unassisted AVF Maturation using a fistulagram and needle sticks to assess maturation at specific time points
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alucent Vessel Restoration System for AVF in people with AV Fistula, run by Alucent Biomedical at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Australia, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kate Ecklund, MPH (3857722300, kecklund@alucentbiomedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AVF Maturation (time frame: 2 weeks to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.