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

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

Study Overview

• Status: Recruiting
• Conditions: Arteriovenous Fistula; Arteriovenous Fistula Stenosis; Dialysis Access Malfunction
• Intervention / Treatment: Device: Angioplasty of all peripheral AVF stenosis

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 Type: Interventional
• Enrollment (Estimated): 94
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Arjunana Sarupraba; Phone Number: 6222 3322; Email: arjunana.sarupraba@sgh.com.sg

Study Locations

• Singapore
  • Singapore, Singapore
    • Recruiting
    • Singapore General Hospital
    • Contact: Arjunana Sarupraba; Phone Number: 6222 3322; Email: arjunana.sarupraba@sgh.com.sg
    • Principal Investigator: Kun Da Zhuang, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drug-coated balloon; Ranger drug-coated balloon will be used for all peripheral AVF stenosis.	Device: Angioplasty of all peripheral AVF stenosis; All peripheral AVF stenosis are to be treated with the same type of balloon depending on allocation
Active Comparator: Conventional balloon; Conventional balloon will be used for all peripheral AVF stenosis.	Device: Angioplasty of all peripheral AVF stenosis; All peripheral AVF stenosis are to be treated with the same type of balloon depending on allocation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Access circuit primary patency	Time to next clinically-driven intervention	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Singapore General Hospital
• Collaborators: Boston Scientific Corporation; Singapore Clinical Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: August 11, 2024
• First Submitted That Met QC Criteria: August 11, 2024
• First Posted (Actual): August 14, 2024

Study Record Updates

• Last Update Posted (Actual): August 14, 2024
• Last Update Submitted That Met QC Criteria: August 11, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: drug-coated balloon; access circuit patency
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Fistula; Constriction, Pathologic; Arteriovenous Fistula
• Other Study ID Numbers: RANGER

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes