Arteriovenous FistulaPhase 3RANGERNCT06553443
Randomised Clinical Trial Comparing Drug-coated Balloon to Plain Balloon for All Peripheral AVF Stenosis
A Phase 3 study testing Angioplasty of all peripheral AVF stenosis in people with Arteriovenous Fistula and Arteriovenous Fistula Stenosis, run by Singapore General Hospital at 1 site in Singapore.
Trial 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 more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Arteriovenous Fistula, Arteriovenous Fistula Stenosis, Dialysis Access Malfunction
- What is being tested?
- Angioplasty of all peripheral AVF stenosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteSingapore
- Study dates
- 4 Jan 2024to 31 Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
Singapore General Hospital
Singapore
Arjunana Sarupraba, 6222 3322, arjunana.sarupraba@sgh.com.sg
Kun Da Zhuang, MBBS
About this study
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.
- Being tested
- Angioplasty of all peripheral AVF stenosis
- Keywords
- drug-coated balloon, access circuit patency
- Medical subject headings
- Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angioplasty of all peripheral AVF stenosisDevice
All peripheral AVF stenosis are to be treated with the same type of balloon depending on allocation
| Study group | Role | What they receive |
|---|---|---|
| Drug-coated balloon | Experimental | Ranger drug-coated balloon will be used for all peripheral AVF stenosis. Receives: Device: Angioplasty of all peripheral AVF stenosis |
| Conventional balloon | Active comparator | Conventional balloon will be used for all peripheral AVF stenosis. Receives: Device: Angioplasty of all peripheral AVF stenosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Access circuit primary patency
Time to next clinically-driven intervention
Measured: 6 months
Secondary outcomes (5)
Access access circuit patency
Time to next clinically-driven intervention
Measured: 12 months
Access circuit assisted primary patency
Time to next access thrombosis or surgical intervention.
Measured: 6 and 12 months
Access circuit secondary patency
Time to access abandonment or surgical revision / declotting
Measured: 6 and 12 months
Procedural complication
Complication related to procedure
Measured: 12 months
Mortality
All cause mortality
Measured: 12 months and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start4 Jan 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arteriovenous FistulaStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore Clinical Research Institute, Boston Scientific Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553443
- Sponsor's protocol ID
- RANGER
- Acronym
- RANGER
- Status last verified
- Aug 2024
- First submitted
- 11 Aug 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Clinical Trial Comparing Drug-coated Balloon to Plain Balloon for All Peripheral AVF Stenosis
- ClinicalTrials.gov ID
- NCT06553443
- Acronym / sponsor ID
- RANGER / RANGER
- Keywords
- drug-coated balloon, access circuit patency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- Singapore Clinical Research Institute, Boston Scientific Corporation
- Study start
- 4 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 14 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug-coated balloon | Experimental | Device: Angioplasty of all peripheral AVF stenosisRanger drug-coated balloon will be used for all peripheral AVF stenosis. |
| Conventional balloon | Active comparator | Device: Angioplasty of all peripheral AVF stenosisConventional balloon will be used for all peripheral AVF stenosis. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Angioplasty of all peripheral AVF stenosisAll peripheral AVF stenosis are to be treated with the same type of balloon depending on allocation | Device | Conventional balloon, Drug-coated balloon |
Primary outcome
Access circuit primary patency
Time frame: 6 months
Time to next clinically-driven intervention
5 secondary outcomes
Access access circuit patency
Time frame: 12 months
Access circuit assisted primary patency
Time frame: 6 and 12 months
Access circuit secondary patency
Time frame: 6 and 12 months
Procedural complication
Time frame: 12 months
Mortality
Time frame: 12 months and 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Angioplasty of all peripheral AVF stenosis in people with Arteriovenous Fistula and Arteriovenous Fistula Stenosis, run by Singapore General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arjunana Sarupraba (6222 3322, arjunana.sarupraba@sgh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Access circuit primary patency (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024; AzTrials last refreshed its copy on 6 Nov 2026.