ClinicalTrials.gg
RecruitingNCT06553443RANGERUpdated Aug 14, 2024

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

A Phase 3 interventional study of Angioplasty of all peripheral AVF stenosis in Arteriovenous Fistula, Arteriovenous Fistula Stenosis and Dialysis Access Malfunction, sponsored by Singapore General Hospital. Recruiting at 1 site in Singapore. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2024-08-14.

Sponsored by Singapore General Hospital · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Registered 7 months after the study started (first participant enrolled Jan 2024, registered Aug 2024).
  • Started Jan 2024; still recruiting 2 years 10 months later.

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Phase
Phase 3
Study type
Interventional
Enrollment
94
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 11 studies in Arteriovenous Fistula with a site in Singapore — 1 open to participants now, 1 under way, 1 of them phase 3. Arteriovenous Fistula · Singapore.

Started
2024
the only one that year
Phase 3
Only one
of the 11
Registered
11th of 11
by date
Lead sponsor
7 of 11
Singapore General Hospital

Among the 11 studies in Arteriovenous Fistula with a site in Singapore, this one is the only one that started in 2024, is the only one in phase 3, and was the 11th registered.

Arteriovenous Fistula

248 studies on the registry are indexed under Arteriovenous Fistula; 44 are open to participants now.

Browse Arteriovenous Fistula studies →

Open to participants now

1 of the 11 studies in Arteriovenous Fistula with a site in Singapore is open now.

A study can be open while its sites in Singapore have not opened yet or have stopped. Only those recruiting at a site in Singapore →

Who these studies take

Of the 27 Arteriovenous Fistula studies recruiting now, 13 (48%) set no upper age limit and 4 (15%) stop at 75 or younger; 3 take children under 18; 2 take healthy volunteers.

This study: 21 Years and older · all sexes · no healthy volunteers.

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02

Study 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

Read the 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.

03

Conditions studied

  • Arteriovenous Fistula
  • Arteriovenous Fistula Stenosis
  • Dialysis Access Malfunction

Browse trials for

Keywords

  • drug-coated balloon
  • access circuit patency
04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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. 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 drug, biologic or device trial that may have an impact on the dialysis access or previous enrolment in this study.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
94 participants (estimated)

Study arms

  • Experimental
    Drug-coated balloon

    Ranger drug-coated balloon will be used for all peripheral AVF stenosis.

    Device: Angioplasty of all peripheral AVF stenosis

  • Active comparator
    Conventional balloon

    Conventional balloon will be used for all peripheral AVF stenosis.

    Device: Angioplasty of all peripheral AVF stenosis

Interventions

  • DeviceAngioplasty of all peripheral AVF stenosis

    All peripheral AVF stenosis are to be treated with the same type of balloon depending on allocation

06

What researchers measure

Primary outcomes

  1. Access circuit primary patency

    Time to next clinically-driven intervention

    Time frame: 6 months

Secondary outcomes

  1. Access access circuit patency

    Time to next clinically-driven intervention

    Time frame: 12 months

  2. Access circuit assisted primary patency

    Time to next access thrombosis or surgical intervention.

    Time frame: 6 and 12 months

  3. Access circuit secondary patency

    Time to access abandonment or surgical revision / declotting

    Time frame: 6 and 12 months

  4. Procedural complication

    Complication related to procedure

    Time frame: 12 months

  5. Mortality

    All cause mortality

    Time frame: 12 months and 5 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2024 (actual). Primary completion is estimated for Dec 2025, 23 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 11, 2024
First posted
Aug 14, 2024
StartActual
Jan 4, 2024
Primary completionEst.
Dec 31, 2025
CompletionEst.
Dec 31, 2029
Last update
Aug 14, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06553443
Collaborators
Singapore Clinical Research Institute, Boston Scientific Corporation
Responsible party
Sponsor
First posted
Aug 14, 2024
Start date
Jan 4, 2024
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Aug 14, 2024

Study contacts

Arjunana Sarupraba
Contact
arjunana.sarupraba@sgh.com.sg
6222 3322

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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