Using a new system to improve blood vessel function for kidney disease patients
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
NA · Alucent Biomedical · NCT05462223
This study is testing a new system to see if it can help improve blood flow in the blood vessels of kidney disease patients who are not yet on dialysis.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Alucent Biomedical (industry) |
| Locations | 12 sites (Camperdown, New South Wales and 11 other locations) |
| Trial ID | NCT05462223 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and feasibility of the Alucent Vessel Restoration System for enhancing the maturation of arteriovenous fistulas (AVF) in patients with chronic kidney disease stage V who are not yet on dialysis. The intervention aims to promote better blood flow and function of the fistula, which is crucial for future dialysis treatment. Participants will be monitored for their response to the treatment and any potential side effects. The study is designed to gather preliminary data that could support further research in this area.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with chronic kidney disease stage V who can provide informed consent.
Not a fit: Patients who are currently receiving hemodialysis or have conditions such as Long COVID may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the readiness of patients for dialysis by enhancing the function of their vascular access.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving vascular access for dialysis, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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"
Where this trial is running
Camperdown, New South Wales and 11 other locations
- Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia (RECRUITING)
- Prince of Wales — Randwick, New South Wales, Australia (RECRUITING)
- Royal North Shore Hospital & North Shore Private — Saint Leonards, New South Wales, Australia (RECRUITING)
- Royal Adelaide Hospital — Adelaide, South Australia, Australia (RECRUITING)
- Flinders Medical Center — Bedford Park, South Australia, Australia (RECRUITING)
- The Alfred Hospital — Melbourne, Victoria, Australia (RECRUITING)
- Northern Health — Richmond, Victoria, Australia (RECRUITING)
- Royal Perth Hospital — Perth, Western Australia, Australia (RECRUITING)
- Poznan University of Medical Sciences — Lublin, Poland (RECRUITING)
- Wojskowy Instytut Medczny z Centrainym Szpitalem Klinicznym Ministerstwa Obrony Narodowej — Warsaw, Poland (RECRUITING)
- Lower Silesia Center of Heart Diseases MEDINet — Wrocław, Poland (RECRUITING)
- Klincznny Oddzial Chirurgii Naczyniowej Szpital Uniweryzstecki w Zielonej — Zielona Góra, Poland (RECRUITING)
Study contacts
- Study coordinator: Kate Ecklund, MPH
- Email: kecklund@alucentbiomedical.com
- Phone: 3857722300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: AV Fistula