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Alucent Vessel Restoration System for AVF

RECRUITING

Feasibility of the Vessel Restoration System for AVF.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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"

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2022-07-15

Primary completion: 2024-05-15

Study completion finish: 2024-12-15

Study type

TREATMENT

Phase

Trial ID

NCT05462223

Intervention or treatment

COMBINATION_PRODUCT: Alucent Vessel Restoration System for AVF

Conditions

• AV Fistula

Condition: AV Fistula
COMBINATION_PRODUCT: Alucent Vessel Restoration System for AVF
Camperdown, New South Wales, Australia and more
Sponsor: Alucent Biomedical

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Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Royal Prince Alfred Hospital

Research sites nearby

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Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Royal Perth Hospital
Perth, Western Australia, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
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	COMBINATION_PRODUCT: 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

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
AVF Maturation	Unassisted AVF Maturation using a fistulagram and needle sticks to assess maturation at specific time points	2 weeks to 3 months

Secondary outcome

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: Alucent Vessel Restoration System for AVF