NCT06771973Not yet recruiting
Ultrasound Prediction of Successful Balloon Assisted AVF Maturation
A Prospective Cohort Study Analysing Prediction of Successful Arteriovenous Fistula (AVF) Maturation Post Balloon Assisted Fistuloplasty With Duplex Ultrasound and Inflammatory Biomarkers
Source: ClinicalTrials.gov · Last updated 15 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
An arteriovenous fistula (AVF) is created to allow for cleaning of the blood in patients with severe kidney disease. An artery and a vein are surgically connected, typically in the arm. This connection changes how the blood flows through the vessels, creating much higher flow in the arm vein than before the operation. Higher blood flow enables blood flow to be cleaned externally with a machine replacing the function of the kidneys. This process is known as dialysis. However, a period known as maturation is required before an AVF can be used in this way. During this time, the vessels grow in size and blood flow continues to increase. In some cases this does not happen and a procedure is required to help the AVF to mature. AVFs not likely to mature may undergo a procedure, known as balloon assisted maturation (BAM), in which a balloon on the end of a catheter is inserted into the AVF vein and inflated. This is typically needed if an AVF is not likely to develop in a way that can be used for dialysis. Blood cleaning, or haemodialysis, is vital in patients with end stage renal disease, or kidney failure. Blood flow measurement using ultrasound, and routine blood test results, may help us predict which AVFs will respond better to BAM. Ultrasound can be used in the clinic setting and can provide the consultants responsible for the patients ongoing management with information that can enable decisions to be made at an early opportunity, and allowing the participants to be involved in future management decisions. This study aims to identify features of the blood flow following the BAM procedure that might be used to predict if the AVF will successfully mature.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 40 (estimated)
- First submitted
- 8 Jan 2025
- Start date
- Jan 2025
- Primary completion date
- Mar 2026
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Diseases
- Chronic kidney disease
- NCT number
- NCT06771973
What you commit to
- Study type: Observational
- Planned participants: 40
- From Jan 2025 to the primary completion date, Mar 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous BAM procedures performed to facilitate maturation
Other
- Brachio-basilic AVFs requiring transposition and superficialisation procedures during maturation phase
- Patients with arterio-venous grafts (AVGs) for vascular access
- AVF unsuitable for BAM procedure or BAM procedure not performed
Who the study is looking for
- Adult patients (\>18 years of age) referred for BAM procedure due to immature native AVF
- AVFs with radio-cephalic or brachio-cephalic configuration
- AVF suitable for endovascular BAM procedure
- Patient is able to provide informed consent
- Patient is willing and able to comply with the study-related procedures
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.