A prospective randomized trial designed to compare the efficacy and safety of Sirolimus coated balloon (SCB) versus paclitaxel coated balloon (DCB) in the treatment of femoropopliteal artery stenosis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
166
Sirolimus-eluting balloon catheter designed and produced by Acotec
Paclitaxel-eluting balloon catheter (trade name:DHALIA)
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe primary patency rate of target lesion at 12 months post-procedure
Defined as freedom from clinically driven target lesion revascularization (CD-TLR) and binary restenosis (restenosis defined as duplex ultrasound (DUS) peak systolic velocity ratio (PSVR) ≥2.4)
Time frame: 12 months post-procedure
Rate of device success
Defined as successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP)
Time frame: immediate post-procedure
Rate of clinically driven target lesion revascularization (CD-TLR) at 12 months post-procedure
Defined as any reintervention at the target lesion due to symptoms or the following index: drop of ABI \>20% or ABI \>0.15 compared to the post-procedure ABI during 12 months post-procedure
Time frame: 12 months post-procedure
The change of Rutherford class from baseline
Defined as change in target limb Rutherford class from baseline to 12 months
Time frame: 12 months post-procedure
The change of ankle-brachial index (ABI) from baseline
Defined as change of target limb ABI from baseline to 12 months
Time frame: 12 months post-procedure
Rate of composite safety endpoint
Defined a composite rate of device-related or procedure-related death, major target limb amputation (above-the-ankle amputation), clinically driven target lesion revascularization (CD-TLR) or target lesion thrombotic events through 30 days post- procedure
Time frame: 30 days post-procedure
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