The objective of this prospective,multi-center,single arm study is to obtain further data on the safety and performance of the Acotec Orchid&Dhalia Drug-coated Balloon catheters for the treatment of for the obstructive lesions in the native Arteriovenous Dialysis Fistulae (AVF).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
164
Trade name of DCB catheter:Acoart Orchid&Dhalia
Beijing Haidian Hospital
Beijing, China
RECRUITINGTarget Lesion Primary Patency Rate
Defined as freedom from clinically-driven target lesion revascularization (CD-TLR) or access circuit thrombosis measured.
Time frame: 6 months
Serious Adverse Event Rate
Defined as the Serious Adverse Event (SAE) rate involving the AV access circuit.
Time frame: 30 days
Target Lesion Primary Patency Rate
Defined as freedom from CD-TLR or access thrombosis occurring in the target lesion post-procedure.
Time frame: 12 months,24 months
All-cause mortality Rate
All-cause mortality post procedure
Time frame: 24 months
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