Alucent Vessel Restoration System for AVF (Activate AVF)

Alucent Biomedical

Status: Enrolling

Conditions: AV Fistula

Treatments: Combination Product: Alucent Vessel Restoration System for AVF

Study type: Interventional

Funder types: Industry

Identifiers

NCT05462223

1061-003

Details and patient eligibility

About

Feasibility of the Vessel Restoration System for AVF

Full 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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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"

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Alucent VRS for Treatment of Atherosclerotic Lesions

Experimental group

Description:

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

Treatment:

Combination Product: Alucent Vessel Restoration System for AVF