Ultrasound-guided fistuloplasty for arteriovenous access dysfunction

A Randomized Controlled Study on the Efficacy of Ultrasound-guided Fistuloplasty in Comparison to Fluoroscopy-guided Fistuloplasty in Patients With Arteriovenous Access Flow Dysfunction

This study is testing if using ultrasound for a procedure to fix blood flow problems in dialysis access works better than the traditional method using X-rays.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 54 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: University of Malaya (Academic / other)
• Locations: 2 sites (Kuala Lumpur, Kuala Lumpur and 1 other locations)
• Trial ID: NCT06480331 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of ultrasound-guided fistuloplasty compared to conventional fluoroscopy-guided fistuloplasty in patients experiencing arteriovenous access flow dysfunction. Participants will be randomly assigned to one of the two intervention groups and will undergo the procedure in a sterile operating environment. The study aims to assess the patency rates at six months post-procedure, with follow-up visits at one, three, and six months to monitor outcomes and any complications.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with native arteriovenous fistulas showing signs of dysfunction.

Not a fit: Patients with prior fistuloplasty, thrombosed fistulas, or non-mature arteriovenous fistulas may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a safer, radiation-free option for patients requiring fistuloplasty.

How similar studies have performed: While the use of ultrasound in vascular interventions is gaining traction, this specific comparison of ultrasound-guided versus fluoroscopy-guided fistuloplasty is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Patient able to comprehend English or Malay language.
2. Patient aged ⩾18 years and ⩽80 years.
3. Patient is willing to comply with protocol.
4. Native AVF that is able to provide prescribed dialysis consistently with 2 needles for \>2/3 of dialysis sessions within 4 consecutive weeks.
5. Patient has a reasonable expectation of remaining on haemodialysis for 6 months.
6. Dampened thrill or pulsatile flow.
7. Volume flow (VF) \<500 ml/min.
8. Severe stenosis (\>50%) of arteriovenous (AV) access measured on color image and confirmed by peak systolic velocity (PSV) ratio of ≥3 in the inflow artery, anastomosis, or in the outflow vein.

Exclusion Criteria:

1. Prior history of fistuloplasty.
2. Thrombosed or completely occluded fistula or outflow vein.
3. Non-mature AVF.
4. Arteriovenous grafts.
5. Suspected central vein stenosis/ cephalic arch stenosis - arm edema or Doppler detected suspicion of the same.
6. Non consenting patient.
7. Metastatic cancer or terminal medical condition.
8. Limited life expectancy (\<6 months).
9. Blood coagulation disorders (haemophilia/ Von Willebrand disease/ clotting factor deficiencies/ liver disease).
10. Connective tissue disease (rheumatoid arthritis/ lupus).
11. Sepsis or active infection.
12. Planned access abandonment within 6 months (eg, peritoneal dialysis or transplant).
13. Pregnant women or women of childbearing potential who are not following an effective method of contraception.
14. Allergy or other known contraindication to iodinated media contrast.
15. Patient enrolled in another access maintenance trial.

Where this trial is running

Kuala Lumpur, Kuala Lumpur and 1 other locations

• Kuala Lumpur Hospital, Jalan Pahang, — Kuala Lumpur, Kuala Lumpur, Malaysia (Recruiting)
• University Malaya Medical Centre, Jln Profesor Diraja Ungku Aziz, Seksyen 13, — Petaling Jaya, Kuala Lumpur, Malaysia (Recruiting)

Study contacts

• Study coordinator: Ehab Bin Said

Conditions Fistulas Arteriovenous; Endovascular treatments; Percutaneous; Ultrasound