NCT06553443

Randomised Clinical Trial Comparing Drug-coated Balloon to Plain Balloon for All Peripheral AVF Stenosis

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 94 (estimated)
• Sponsor: Singapore General Hospital · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

To compare the access circuit primary patency after Ranger drug-coated balloon angioplasty of arteriovenous fistula (AVF) stenosis with that after conventional balloon angioplasty

Detailed description

This is a blinded randomized controlled trial recruiting 94 patients with AVF stenosis who will be randomized in a 1:1 ratio to either drug-coated balloon (Ranger) or conventional balloon. All peripheral AVF stenoses will be treated with the allocated balloon type. The primary outcome measure is 6-month access circuit patency.

Conditions

• Arteriovenous Fistula
• Arteriovenous Fistula Stenosis
• Dialysis Access Malfunction

Interventions

Type	Name	Description
DEVICE	Angioplasty of all peripheral AVF stenosis	All peripheral AVF stenosis are to be treated with the same type of balloon depending on allocation

Timeline

• Start date: 2024-01-04
• Primary completion: 2025-12-31
• Completion: 2029-12-31
• First posted: 2024-08-14
• Last updated: 2024-08-14

Locations

1 site across 1 country: Singapore

Regulatory

• FDA-regulated device study