A Prospective, Multi-center Study to Evaluate Efficacy and Safety of BSJ020R in Treatment of AVF for Hemodialysis (RANGER AV Japan Study)
NCT06639451 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 186
Last updated 2026-05-08
Summary
A prospective, multi-center study to evaluate efficacy and safety of BSJ020R in treatment of AVF for hemodialysis
Conditions
- Arteriovenous Fistula Stenosis
- Arteriovenous Fistula
- Vascular Access
Interventions
- DEVICE
-
RANGER™ Paclitaxel Coated Balloon Catheter
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.
Sponsors & Collaborators
-
Boston Scientific Corporation
lead INDUSTRY
Principal Investigators
-
Tomonari Ogawa, MD · Saitama Medical Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-12-13
- Primary Completion
- 2026-04-01
- Completion
- 2026-12-31
Countries
- Japan
Study Locations
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