This study is a prospective, multi-center observational study, which evaluates the effectiveness and safety of endovascular therapy in the real world for infrapopliteal arterial occlusive disease from intermittent claudication to chronic threatening limb ischemia.
This study is a prospective, multi-center observational study. This study will be conducted at 38 centers and is expected to enroll more than 3000 patients. And we will evaluate the effectiveness and safety of endovascular therapy in the real world for infrapopliteal arterial occlusive disease from intermittent claudication to chronic threatening limb ischemia.
Study Type
OBSERVATIONAL
Enrollment
3,000
Endovascular treatment for infrapopliteal arterial disease.
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGFreedom from major adverse event rate
Major adverse events include Death, major amputation rates and clinical driven target lesion revascularization (CDTLR).
Time frame: 12 months
Amputation-free survival
Freedom from death and major amputation
Time frame: 12 months
Survival
Freedom from all-cause mortality.
Time frame: 12 months
Freedom from major amputation
Freedom from major amputation
Time frame: 12 months
Freedom from CDTLR
Freedom from clinical driven target lesion revascularization
Time frame: 12 months
Freedom from clinical driven target limb revascularization
Freedom from clinical driven target limb revascularization
Time frame: 12 months
Rutherford categories
Rutherford categories
Time frame: 12 months
Wound condition
Wound and foot infections were scored using WIfI system.
Time frame: 12 months
Complication rates
Minor and Major complications rates.
Time frame: 1 week
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Quality of life score
Vascular quality of life questionnaire was used.
Time frame: 12 months