The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the Acotec Litos\&Tulip Drug-coated Balloon catheters in the treatment of lesions in below-the-knee artery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
107
Trade name of DEB catheter: AcoArt Tulip (0.018") or AcoArt Litos (0.014")
Chui Yang Liu Hospital affiliated to Tsinghua University
Beijing, Beijing Municipality, China
RECRUITINGPrimary Patency
Primary patency rate is defined as freedom from clinically-driven target lesion revascularisation (CD-TLR) , restenosis as determined by duplex ultrasound (DUS) or digital subtraction angiography (DSA) or major target limb amputation.
Time frame: 6 month
Major adverse event (MAE) rate
Defined as a composite rate of all-cause death, target limb major amputation and CD-TLR
Time frame: 30 days
Patency rate
Defined as freedom from clinically-driven target lesion revascularisation (CD-TLR) , restenosis as determined by duplex ultrasound (DUS) or digital subtraction angiography (DSA) or major target limb amputation.
Time frame: 12 months,24 months,36 months,48 months ,60 months
Rate of major target limb amputation
A major adverse limb event is defined as above-ankle amputation of the treated limb
Time frame: 12 months,24 months,36 months,48 months ,60 months
Rate of All-cause mortality
All-cause mortality at 12, 24, 36, 48, 60 months post procedure
Time frame: 12 months,24 months,36 months,48 months ,60 months
Rate of clinically-driven target vessel revascularization (CD-TVR)
Clinically-driven target vessel revascularization (CD-TVR) at 12, 24, 36, 48, 60 months post procedure
Time frame: 12 months,24 months,36 months,48 months ,60 months
Rate of clinically-driven target lesion revascularization (CD-TLR)
Clinically-driven target lesion revascularization (CD-TLR) at 12, 24, 36, 48, 60 months post procedure
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Time frame: 12 months,24 months,36 months,48 months ,60 months
Rate of ulcer healing
Ulcer healed or not; if not, improving, stagnant,worsening
Time frame: 12 months,24 months,36 months,48 months ,60 months
Rate of distal embolization
Rate of distal embolization defined as occurrence significant distal embolization in target limb through the end of the procedure
Time frame: through procedure completion