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

Phase 3

Recruiting

• Conditions: Arteriovenous Fistula Stenosis; Dialysis Access Malfunction; Arteriovenous Fistula
• Interventions: Device: Angioplasty of all peripheral AVF stenosis

• Registration Number: NCT06553443
• Lead Sponsor: Singapore General Hospital

Brief 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.

Study Timeline

• Study Start: 2024-01-04
• Status Verified: 2024-08
• Study First Submitted: 2024-08-11
• Study First Submitted QC: 2024-08-11
• Last Update Submitted: 2024-08-11
• Study First Posted: 2024-08-14
• Last Update Posted: 2024-08-14
• Primary Completion: 2025-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

1. Failing AVF with at least 1 AVF stenosis presenting with any clinical, physiological or haemodynamic abnormalities. Both de novo and recurrent stenosis are accepted.
2. AVF has been used successfully for at least 1 month (non-mature AVF are not allowed).
3. Less than 30% residual stenosis after angioplasty.
4. ≥ 21 years old
5. Informed and valid consent given.

Exclusion Criteria

1. Thrombosed AVFs
2. Haemodynamically significant central vein stenosis
3. Target lesion not treatable with the available sizes of drug eluting balloon (up to 8mm)
4. Contraindication to antiplatelet therapy
5. Coagulopathy or thrombocytopenia that cannot be managed adequately with periprocedural transfusion.
6. Allergy / contraindication to paclitaxel.
7. Acute infection over proposed puncture site.
8. Women who are breastfeeding, pregnant * or planning on becoming pregnant during study.
9. Participant with medical conditions, which in the opinion of the investigator may cause noncompliance with protocol.
10. Currently participating in an investigational drug, biologic or device trial that may have an impact on the dialysis access or previous enrolment in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional balloon	Angioplasty of all peripheral AVF stenosis	Conventional balloon will be used for all peripheral AVF stenosis.
Drug-coated balloon	Angioplasty of all peripheral AVF stenosis	Ranger drug-coated balloon will be used for all peripheral AVF stenosis.

Primary Outcome Measures

Name	Time	Method
Access circuit primary patency	6 months	Time to next clinically-driven intervention

Secondary Outcome Measures

Name	Time	Method
Access circuit secondary patency	6 and 12 months	Time to access abandonment or surgical revision / declotting
Access access circuit patency	12 months	Time to next clinically-driven intervention
Access circuit assisted primary patency	6 and 12 months	Time to next access thrombosis or surgical intervention.
Mortality	12 months and 5 years	All cause mortality
Procedural complication	12 months	Complication related to procedure

Trial Locations

Locations (1)

Singapore General Hospital; 🇸🇬 Singapore, Singapore