Alucent Vessel Restoration System for AVF

NCT ID: NCT05462223

Last Updated: 2024-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-15

Study Completion Date

2024-12-15

Brief Summary

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Feasibility of the Vessel Restoration System for AVF

Detailed Description

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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

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AV Fistula

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Alucent Vessel Restoration System for AVF

Intervention Type COMBINATION_PRODUCT

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

Interventions

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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 Type COMBINATION_PRODUCT

Eligibility Criteria

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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"
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alucent Biomedical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Site Status RECRUITING

Prince of Wales

Randwick, New South Wales, Australia

Site Status RECRUITING

Royal North Shore Hospital & North Shore Private

Saint Leonards, New South Wales, Australia

Site Status RECRUITING

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Site Status RECRUITING

Flinders Medical Center

Bedford Park, South Australia, Australia

Site Status RECRUITING

The Alfred Hospital

Melbourne, Victoria, Australia

Site Status RECRUITING

Northern Health

Richmond, Victoria, Australia

Site Status RECRUITING

Royal Perth Hospital

Perth, Western Australia, Australia

Site Status RECRUITING

Poznan University of Medical Sciences

Lublin, , Poland

Site Status RECRUITING

Wojskowy Instytut Medczny z Centrainym Szpitalem Klinicznym Ministerstwa Obrony Narodowej

Warsaw, , Poland

Site Status RECRUITING

Lower Silesia Center of Heart Diseases MEDINet

Wroclaw, , Poland

Site Status RECRUITING

Klincznny Oddzial Chirurgii Naczyniowej Szpital Uniweryzstecki w Zielonej

Zielona Góra, , Poland

Site Status RECRUITING

Countries

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Australia Poland

Central Contacts

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Kate Ecklund, MPH

Role: CONTACT

3857722300

Facility Contacts

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Lisa Turner

Role: primary

0431025843

Elena Matthews

Role: primary

0433834022

Linda Pallot

Role: primary

0413883344

Bronwyn Hockley

Role: primary

0870743077

Mel Toomey

Role: primary

Helen Kavnoudias

Role: primary

0390763606

Kira Edwards

Role: primary

0422312452

Jackie Wong

Role: primary

0892240226

Other Identifiers

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1061-003

Identifier Type: -

Identifier Source: org_study_id

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