The purpose of this study is to demonstrate the safety and effectiveness of the use of NMB's percutaneous transluminal angioplasty (PTA) for the treatment of obstructive lesions of Arteriovenous (AV) Dialysis Fistulae/Grafts.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
NMB's PTA Balloon catheter with drug
The Rabin Medical Center, Hasharon Hospital
Petah Tikva, Israel
Restenosis rate
Binary Stenosis is defined as ≥50% narrowing in luminal diameter basen upon comparison with the adjacent normal vessel. Restenosis Rate - comparison shall be performed both to the patient previous data as well as to restenosis rate data published in the literature for standard PTA balloon catheter procedure
Time frame: 6 months
restenosis rate
As defined above in the primary end point
Time frame: 1, 3 and 12 months
Easy insertion and removal
Time frame: intraprocedural
Major adverse events rate
All adverse events will be reviewed by the Investigator and evaluated as follows: * Nature of the event. * Severity of the event - serious, moderate, mild. * Relation of the adverse event to the device - unrelated, possible, definite
Time frame: intraprocedural 1, 3, 6 and 12 months
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