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

NCT06553443 — Phase 3, Recruiting, 94 participants, Singapore General Hospital

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Registry	NCT06553443, acronym RANGER
Status	Recruiting
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	94 (Estimated)
Sponsor	Singapore General Hospital (Other); collaborators: Singapore Clinical Research Institute, Boston Scientific Corporation
Conditions	Arteriovenous Fistula, Arteriovenous Fistula Stenosis, Dialysis Access Malfunction
Interventions	Angioplasty of all peripheral AVF stenosis (Device)
Dates	start 2024-01-04, primary completion 2025-12-31 (estimated), completion 2029-12-31 (estimated), first posted 2024-08-14, last updated 2024-08-14
Locations	1 site in Singapore

-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

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Drug-coated balloon	Experimental	Device: Angioplasty of all peripheral AVF stenosis	Ranger drug-coated balloon will be used for all peripheral AVF stenosis.
Conventional balloon	Active comparator	Device: Angioplasty of all peripheral AVF stenosis	Conventional balloon will be used for all peripheral AVF stenosis.

Angioplasty of all peripheral AVF stenosis (Device): All peripheral AVF stenosis are to be treated with the same type of balloon depending on allocation

+Outcome measures

Primary outcomes

Access circuit primary patency [6 months]: Time to next clinically-driven intervention

Secondary outcomes

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.
Access circuit secondary patency [6 and 12 months]: Time to access abandonment or surgical revision / declotting
Procedural complication [12 months]: Complication related to procedure
Mortality [12 months and 5 years]: All cause mortality

+Eligibility

Sex: All, ages: 21 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Singapore General Hospital	Singapore	Singapore	Recruiting

+Study documents

Study Protocol (PDF, 2022-12-28)