Radiation Free Fistuloplasty is the Way Forward (NCT06480331) | Clinical Trial Compass
RecruitingNot Applicable
Radiation Free Fistuloplasty is the Way Forward
Malaysia54 participantsStarted 2023-07-01
Plain-language summary
The goal of this clinical trial is to study effectiveness of ultrasound-guided fistuloplasty in comparison to conventional fistuloplasty in patients with arteriovenous access flow dysfunction. The main question it aims to answer is:
To investigate patencies in patients with arteriovenous access flow dysfunction receiving ultrasound-guided fistuloplasty versus fluoroscopy-guided fistuloplasty at 6 months
Participants will:
* be randomized equally to ultrasound-guided fistuloplasty group and fluoroscopy-guided fistuloplasty group.
* visit clinic at one month, three month \& six months for checkups and tests.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patient able to comprehend English or Malay language.
✓. Native AVF that is able to provide prescribed dialysis consistently with 2 needles for \>2/3 of dialysis sessions within 4 consecutive weeks.
✓. Patient has a reasonable expectation of remaining on haemodialysis for 6 months.
✓. Dampened thrill or pulsatile flow.
✓. Volume flow (VF) \<500 ml/min.
✓. 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
✕. Prior history of fistuloplasty.
✕. Thrombosed or completely occluded fistula or outflow vein.
What they're measuring
1
To investigate patencies in patients with arteriovenous access flow dysfunction receiving ultrasound-guided fistuloplasty versus fluoroscopy-guided fistuloplasty at 6 months