A prospective, multi-center study to evaluate efficacy and safety of BSJ020R in treatment of AVF for hemodialysis
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
186
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.
Kansai Rosai Hospital
Amagasaki, Hyōgo, Japan
Yokohama Dai-ichi Hospital
Yokohama, Kanagawa, Japan
Kishiwada Tokushukai Hospital
Kishiwada, Osaka, Japan
Osaka Keisatsu Hospital
Osaka, Osaka, Japan
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
Time frame: 6 months post index procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Saitama Medical Center
Kawagoe, Saitama, Japan
Shizuoka General Hospital
Shizuoka, Shizuoka, Japan
Saiseikai Central Hospital
Minato, Tokyo, Japan
Wakayama Medical University Hospital
Wakayama, Wakayama, Japan