A Prospective, Multi-center Study to Evaluate Efficacy and Safety of BSJ020R in Treatment of AVF for Hemodialysis (RANGER AV Japan Study)

NCT06639451 | Active Not Recruiting

• 1 other identifier: S2511
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 8

Brief Summary

A prospective, multi-center study to evaluate efficacy and safety of BSJ020R in treatment of AVF for hemodialysis

Conditions

Arteriovenous Fistula Stenosis; Vascular Access; Arteriovenous Fistula

Outcome Measures

Primary Outcomes (1)

• 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

  6 months post index procedure

Other Outcomes (11)

• Technical success

  Day of index procedure

• Procedure success

  Day of index procedure

• Clinical success

  12 months post-index procedure

Study Arms (1)

RANGER™ Paclitaxel Coated Balloon

EXPERIMENTAL

RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the AVF at the index procedure.

Device: RANGER™ Paclitaxel Coated Balloon Catheter

Interventions

RANGER™ Paclitaxel Coated Balloon Catheter DEVICE

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.

RANGER™ Paclitaxel Coated Balloon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (8)

Kansai Rosai Hospital

Amagasaki, Hyōgo, Japan

Location

Yokohama Dai-ichi Hospital

Yokohama, Kanagawa, Japan

Location

Kishiwada Tokushukai Hospital

Kishiwada, Osaka, Japan

Location

Osaka Keisatsu Hospital

Osaka, Osaka, Japan

Location

Saitama Medical Center

Kawagoe, Saitama, Japan

Location

Shizuoka General Hospital

Shizuoka, Shizuoka, Japan

Location

Saiseikai Central Hospital

Minato, Tokyo, Japan

Location

Wakayama Medical University Hospital

Wakayama, Wakayama, Japan

Location

MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Tomonari Ogawa, MD

  Saitama Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: December 13, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (8)