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Alucent Vessel Restoration System for AVF (Activate AVF)

Primary Purpose

AV Fistula

Status
Recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Alucent Vessel Restoration System for AVF
Sponsored by
Alucent Biomedical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for AV Fistula

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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"

Sites / Locations

  • Flinders Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Alucent VRS for Treatment of Atherosclerotic Lesions

Arm Description

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

Outcomes

Primary Outcome Measures

AVF Maturation
Unassisted AVF Maturation using a fistulagram and needle sticks to assess maturation at specific time points

Secondary Outcome Measures

Full Information

First Posted
July 8, 2022
Last Updated
January 30, 2023
Sponsor
Alucent Biomedical
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1. Study Identification

Unique Protocol Identification Number
NCT05462223
Brief Title
Alucent Vessel Restoration System for AVF
Acronym
Activate AVF
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2022 (Actual)
Primary Completion Date
April 15, 2023 (Anticipated)
Study Completion Date
April 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alucent Biomedical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AV Fistula

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alucent VRS for Treatment of Atherosclerotic Lesions
Arm Type
Experimental
Arm Description
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 Type
Combination Product
Intervention Name(s)
Alucent Vessel Restoration System for AVF
Intervention Description
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
Primary Outcome Measure Information:
Title
AVF Maturation
Description
Unassisted AVF Maturation using a fistulagram and needle sticks to assess maturation at specific time points
Time Frame
2 weeks to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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"
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hank Hauser
Phone
3854234044
Email
hhauser@alucentbiomedical.com
First Name & Middle Initial & Last Name or Official Title & Degree
Anuraag Visweswaran
Email
avisweswaran@alucentbiomedical.com
Facility Information:
Facility Name
Flinders Medical Center
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mel Toomey
Phone
82045445
Email
melanie.toomey@sa.gov.au

12. IPD Sharing Statement

Learn more about this trial

Alucent Vessel Restoration System for AVF

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