This is a prospective, multicenter, single arm study, to support the safety and effectiveness assessment of the Shockwave Medical Peripheral IVL System applied to Chinese patients
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
To assess the safety and effectiveness of IVL treatment used in combination with DCB to treat moderate and severely calcified femoropopliteal arteries
Affilated Hanzhou First People's Hospital, Zhejiang University School of Medicine
Shanghai, China
Huashan Hospital
Shanghai, China
Shanghai Jiaotong university school of medicine,Renji Hospital
Shanghai, China
Shanghai Jiaotong University School of Medicine,The Ninth People's Hospital
Shanghai, China
Procedural success
defined as residual stenosis ≤30% without flow-limiting dissection (≥ grade D) post IVL treatment (prior to DCB)by angiographic core lab
Time frame: Immediately post index procedure
Major Adverse Event (MAE) at 30 days
defined as: * Need for emergency surgical revascularization of target limb * Unplanned target limb major amputation (above the ankle) * Symptomatic thrombus or distal emboli that require surgical, mechanical or pharmacologic means to improve flow and extend hospitalization * Perforations that require an intervention, including bail-out stenting
Time frame: 30 days post index procedure
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Zhongshan Hospital
Shanghai, China