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Recruiting NCT06480331

Radiation Free Fistuloplasty is the Way Forward

Trial Parameters

Condition Fistulas Arteriovenous
Sponsor University of Malaya
Study Type INTERVENTIONAL
Phase N/A
Enrollment 54
Sex ALL
Min Age 18 Years
Max Age 80 Years
Start Date 2023-07-01
Completion 2024-12-31
Interventions
Ultrasound-guided fistuloplastyFluoroscopy-guided fistuloplasty

Brief 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.

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 me

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