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

Singapore General Hospital1 site in 1 country94 target enrollmentJanuary 4, 2024

ConditionsArteriovenous Fistula Arteriovenous Fistula Stenosis Dialysis Access Malfunction

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Arteriovenous Fistula
Sponsor: Singapore General Hospital
Enrollment: 94
Locations: 1
Primary Endpoint: Access circuit primary patency
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 4, 2024

End Date

December 31, 2029

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Singapore General Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

•Thrombosed AVFs
•Haemodynamically significant central vein stenosis
•Target lesion not treatable with the available sizes of drug eluting balloon (up to 8mm)
•Contraindication to antiplatelet therapy
•Coagulopathy or thrombocytopenia that cannot be managed adequately with periprocedural transfusion.
•Allergy / contraindication to paclitaxel.
•Acute infection over proposed puncture site.
•Women who are breastfeeding, pregnant \* or planning on becoming pregnant during study.
•Participant with medical conditions, which in the opinion of the investigator may cause noncompliance with protocol.
•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.