NCT05462223

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Alucent Biomedical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• AV Fistula

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-07-15
• Primary completion: 2024-05-15
• Completion: 2024-12-15
• First posted: 2022-07-18
• Last updated: 2024-03-13

Locations

12 sites across 2 countries: Australia, Poland