Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2026-01-02 @ 8:08 AM
Study NCT ID:
NCT06639451
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-18
First Post:
2024-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective, Multi-center Study to Evaluate Efficacy and Safety of BSJ020R in Treatment of AVF for Hemodialysis (RANGER AV Japan Study)
Sponsor:
Boston Scientific Corporation
Organization:
Study Overview
Official Title:
A Prospective, Multi-center Study to Evaluate Efficacy and Safety of BSJ020R in Treatment of AVF for Hemodialysis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: