Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06639451
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-09
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:
None
Organization:
None
Study Overview
Official Title:
A Prospective Multi-center Study to Evaluate Efficacy and Safety of BSJ020R in Treatment of AVF for Hemodialysis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None