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: Recruiting
Location: See all (12) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Feasibility of the Vessel Restoration System for AVF
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 18 years of age and can provide informed consent
• Use birth control
• Chronic Kidney Disease
Locations
Other Locations
Australia
Royal Adelaide Hospital
RECRUITING
Adelaide
Flinders Medical Center
RECRUITING
Bedford Park
Royal Prince Alfred Hospital
RECRUITING
Camperdown
The Alfred Hospital
RECRUITING
Melbourne
Royal Perth Hospital
RECRUITING
Perth
Prince of Wales
RECRUITING
Randwick
Northern Health
RECRUITING
Richmond
Royal North Shore Hospital & North Shore Private
RECRUITING
Saint Leonards
Poland
Poznan University of Medical Sciences
RECRUITING
Lublin
Wojskowy Instytut Medczny z Centrainym Szpitalem Klinicznym Ministerstwa Obrony Narodowej
RECRUITING
Warsaw
Lower Silesia Center of Heart Diseases MEDINet
RECRUITING
Wroclaw
Klincznny Oddzial Chirurgii Naczyniowej Szpital Uniweryzstecki w Zielonej
RECRUITING
Zielona Góra
Contact Information
Primary
Kate Ecklund, MPH
kecklund@alucentbiomedical.com
3857722300
Time Frame
Start Date: 2022-07-15
Estimated Completion Date: 2024-12-15
Participants
Target number of participants: 30
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Alucent Biomedical