Arteriovenous Fistula StenosisNCT06639451
A Prospective, Multi-center Study to Evaluate Efficacy and Safety of BSJ020R in Treatment of AVF for Hemodialysis (RANGER AV Japan Study)
A study testing RANGER™ Paclitaxel Coated Balloon Catheter in people with Arteriovenous Fistula Stenosis and Arteriovenous Fistula, run by Boston Scientific Corporation at 8 sites in Japan.
Trial summary
A prospective, multi-center study to evaluate efficacy and safety of BSJ020R in treatment of AVF for hemodialysis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arteriovenous Fistula Stenosis, Arteriovenous Fistula, Vascular Access
- What is being tested?
- RANGER™ Paclitaxel Coated Balloon Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 8 sitesJapan
- Study dates
- 13 Dec 2024to 31 Dec 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is willing and able to provide consent before any study-specific tests or procedures are performed and agree to attend all required follow-up visits.
- Subject at least 18 years of age.
- Subject has a native AV fistula created ≥ 60 days prior to enrollment.
- The target AVF has undergone successful dialysis for at least 8 of 12 sessions during a four-week period prior to enrollment.
- Subjects on stable dialysis has all of the following criteria meet.
- No significant decrease in blood pressure during dialysis during a four-week period prior to enrollment
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- No significant edema
- No signs of heart failure
- Target lesion is located between the arteriovenous anastomosis and axillosubclavian junction.
- Note: If the lesion is in the anastomosis, the treatment may be delivered up to 2 cm upstream on the arterial side. Note: If the lesion is in the cephalic arch, the treatment may be delivered up to 2 cm into the subclavian vein.
- Angiographic evidence that target lesion consists of a de novo and/or non-stented restenotic lesion with ≥ 50% stenosis by visual estimate.
- Most recent standard PTA (ie. non-drug coated) treatment must be \> 3 months prior to enrollment and most recent DCB treatment must be \> 6 months prior to enrollment.
- A target lesion with total lesion length up to 130 mm by visual estimate. Note: Tandem (or "adjacent") lesions may be enrolled provided they meet all of the following criteria:
- Separated by a gap of ≤ 30mm (3 cm).
- Total combined lesion length, including 30 mm gap, is ≤ 130 mm.
- Able to be treated as a single lesion.
- Reference vessel diameter ≥ 4.0 mm and ≤ 8.0 mm by visual estimate.
- Subject underwent successful crossing of the target lesion with the guide wire and pre-dilatation with only high pressure PTA balloon(s) defined as:
- Residual stenosis of ≤ 30% AND.
- Absence of a flow limiting dissection (Grade ≥ C) or perforation.
Who cannot join
- Life expectancy, documented in the investigator's opinion, of less than 12 months.
- Receiving immunosuppressive therapy.
- Anticipating a kidney transplant within 6 months of enrollment into the study.
- Patient with anticipated conversion to peritoneal dialysis.
- Patient with AVF infection or systemic infection.
- Patient has planned surgical revision of AVF.
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- Presence of secondary non-target lesion requiring treatment within 30-days post index procedure.
- Patient with hemodynamically significant central venous stenoses that cannot be successfully treated prior to treatment of the target lesion.
- Patient with target AVF or access circuit which had within 1 year prior to enrollment or currently has a thrombosis.
- Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the delivery system.
- Target lesion located central to the axillosubclavian junction.
- Patient has significant arterial inflow lesion requiring treatment more than 2 cm upstream from the anastomosis in the AVF.
- Presence of aneurysm requiring treatment at the lesion site.
- Presence of a stent or graft located in the target access circuit.
- Known allergies or sensitivities to paclitaxel and/or raw materials of test devices including ATBC (refer to Kiki-gaiyosho).
- Known contraindication, including allergic reaction, or sensitivity to contrast material that, in the opinion of the investigator, cannot be adequately pretreated.
- Patient who cannot receive antiplatelet and/or anticoagulant therapy in accordance with the investigator's direction.
- Clinically significant Steal Syndrome requiring treatment.
- Women who are breastfeeding, pregnant, or the subject with known intention to procreate within 6 months after index procedure. Note: 6-month contraception after index procedure is required.
- Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint, or subject was previously enrolled in this study.
- Subject intends to participate in another investigational drug or device clinical trial within 6 months after the index procedure.
- Patient has a co-morbid condition that, in the opinion of the investigator, may cause him/her to be non-compliant with the protocol or confound the data interpretation.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Kansai Rosai Hospital
Amagasaki, Hyōgo
Saitama Medical Center
Kawagoe, Saitama
Kishiwada Tokushukai Hospital
Kishiwada, Osaka
Saiseikai Central Hospital
Minato, Tokyo
Osaka Keisatsu Hospital
Osaka, Osaka
Shizuoka General Hospital
Shizuoka, Shizuoka
Wakayama Medical University Hospital
Wakayama, Wakayama
Yokohama Dai-ichi Hospital
Yokohama, Kanagawa
About this study
Official title: A Prospective, Multi-center Study to Evaluate Efficacy and Safety of BSJ020R in Treatment of AVF for Hemodialysis
A prospective, multi-center study to evaluate efficacy and safety of BSJ020R in treatment of AVF for hemodialysis
Read the detailed description
Primary objective of this study is to evaluate the effectiveness and safety of the Ranger™ Paclitaxel Coated Balloon Catheter for treating subjects presenting with de novo or non-stented restenotic lesions of native arteriovenous dialysis fistulae (AVF) in the upper extremity.
The primary endpoint is the target lesion primary patency (TLPP) rate at 6 months post index procedure. Primary patency is a binary endpoint, defined as freedom from clinically-driven target lesion revascularization (clinically-driven TLR) or access circuit thrombosis measured at 6 months post index procedure.
- Being tested
- RANGER™ Paclitaxel Coated Balloon Catheter
- Medical subject headings
- Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RANGER™ Paclitaxel Coated Balloon CatheterDevice
A procedure that utilizes a balloon coated with paclitaxel (drug) which can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a balloon coated with paclitaxel at the end of it. When the tube is in place, it inflates to open the blood vessel, so that normal blood flow is restored. The tube is then removed.
| Study group | Role | What they receive |
|---|---|---|
| RANGER™ Paclitaxel Coated Balloon | Experimental | RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the AVF at the index procedure. Receives: Device: RANGER™ Paclitaxel Coated Balloon Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target lesion primary patency rate
Primary patency is a binary endpoint, defined as freedom from clinically-driven target lesion revascularization (clinically-driven TLR) or access circuit thrombosis measured at 6 months post index procedure.
Note: Clinically-driven TLR is defined as any re-intervention involving the target lesion in which:
- The subject has a ≥50% diameter stenosis (per angiographic core laboratory assessment) in the presence of clinical or physiologic abnormalities that indicate dialysis access dysfunction OR
- ≥70% stenosis (per angiographic core laboratory assessment) without the presence of clinical or physiologic abnormalities indicating dialysis access dysfunction
Measured: 6 months post index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start13 Dec 2024
- Primary completion1 Apr 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arteriovenous Fistula StenosisStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tomonari Ogawa, MD, Principal investigator, Saitama Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639451
- Sponsor's protocol ID
- S2511
- Status last verified
- May 2026
- First submitted
- 9 Oct 2024
- Last updated
- 8 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan so far, but the anonymized data and study protocol for this clinical trial may be made available to other researchers in accordance with Boston Scientific Data Sharing Policy: (http://www.bostonscientific.com/en-US/data-sharing-requests.html)
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center Study to Evaluate Efficacy and Safety of BSJ020R in Treatment of AVF for Hemodialysis
- ClinicalTrials.gov ID
- NCT06639451
- Acronym / sponsor ID
- S2511
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2024 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Oct 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.
A prospective, multi-center study to evaluate efficacy and safety of BSJ020R in treatment of AVF for hemodialysis
Detailed description
Primary objective of this study is to evaluate the effectiveness and safety of the Ranger™ Paclitaxel Coated Balloon Catheter for treating subjects presenting with de novo or non-stented restenotic lesions of native arteriovenous dialysis fistulae (AVF) in the upper extremity.
The primary endpoint is the target lesion primary patency (TLPP) rate at 6 months post index procedure. Primary patency is a binary endpoint, defined as freedom from clinically-driven target lesion revascularization (clinically-driven TLR) or access circuit thrombosis measured at 6 months post index procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RANGER™ Paclitaxel Coated Balloon | Experimental | Device: RANGER™ Paclitaxel Coated Balloon CatheterRANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the AVF at the index procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Subject is willing and able to provide consent before any study-specific tests or procedures are performed and agree to attend all required follow-up visits.
- Subject at least 18 years of age.
- Subject has a native AV fistula created ≥ 60 days prior to enrollment.
- The target AVF has undergone successful dialysis for at least 8 of 12 sessions during a four-week period prior to enrollment.
- Subjects on stable dialysis has all of the following criteria meet.
Key exclusion criteria (22 listed)
- Life expectancy, documented in the investigator's opinion, of less than 12 months.
- Receiving immunosuppressive therapy.
- Anticipating a kidney transplant within 6 months of enrollment into the study.
- Patient with anticipated conversion to peritoneal dialysis.
- Patient with AVF infection or systemic infection.
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 |
|---|---|---|
| RANGER™ Paclitaxel Coated Balloon CatheterA procedure that utilizes a balloon coated with paclitaxel (drug) which can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a balloon coated with paclitaxel at the end of it. When the tube is in place, it inflates to open the blood vessel, so that normal blood flow is restored. The tube is then removed. | Device | RANGER™ Paclitaxel Coated Balloon |
Primary outcome
Target lesion primary patency rate
Time frame: 6 months post index procedure
Primary patency is a binary endpoint, defined as freedom from clinically-driven target lesion revascularization (clinically-driven TLR) or access circuit thrombosis measured at 6 months post index procedure. Note: Clinically-driven TLR is defined as any re-intervention involving the target lesion in which: * The subject has a ≥50% diameter stenosis (per angiographic core laboratory assessment) in the presence of clinical or physiologic abnormalities that indicate dialysis access dysfunction OR * ≥70% stenosis (per angiographic core laboratory assessment) without the presence of clinical or physiologic abnormalities indicating dialysis access dysfunction
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 8 May 2026.
- Individual participant dataSharing planned: No. No plan so far, but the anonymized data and study protocol for this clinical trial may be made available to other researchers in accordance with Boston Scientific Data Sharing Policy: (http://www.bostonscientific.com/en-US/data-sharing-requests.html)
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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. This study is not recruiting at the moment.
Tomonari Ogawa, MD principal investigator
Saitama Medical Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RANGER™ Paclitaxel Coated Balloon Catheter in people with Arteriovenous Fistula Stenosis and Arteriovenous Fistula, run by Boston Scientific Corporation at 8 sites in Japan.
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 20 inclusion and 22 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: under way, not looking for participants, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Japan. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target lesion primary patency rate (time frame: 6 months post index procedure). 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 8 May 2026.