Active — Not RecruitingNot Applicable

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

Japan186 participantsStarted 2024-12-13

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.
✓. Target lesion is located between the arteriovenous anastomosis and axillosubclavian junction.
✓. 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.

✕. 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.

Target lesion primary patency rate

Timeframe: 6 months post index procedure

NCT IDNCT06639451

SponsorBoston Scientific Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04-01

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.
✓. Target lesion is located between the arteriovenous anastomosis and axillosubclavian junction.
✓. 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.

✕. 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.