RecruitingNot ApplicableNCT05462223
Alucent Vessel Restoration System for AVF
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
Sponsor
Alucent Biomedical
Enrollment
30 participants
Start Date
Jul 15, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
Feasibility of the Vessel Restoration System for AVF
Eligibility
Min Age: 18 Years
Inclusion Criteria3
- years of age and can provide informed consent
- Use birth control
- Chronic Kidney Disease
Exclusion Criteria4
- Receiving hemodialysis
- Pregnant, breastfeeding, planning to become pregnant
- Receiving immunosuppressants
- Has "Long COVID"
Interventions
COMBINATION_PRODUCTAlucent 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
Locations(12)
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NCT05462223