Results of Endovascular Treatment for Infrapopliteal Arterial Occlusive Disease.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Results of Endovascular Treatment for Infrapopliteal Arterial Occlusive Disease: a Prospective, Multicenter, Real-world Study

Conditions
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Infrapopliteal Artery Occlusive Disease, Endovascular Treatment

Intervention / Treatment
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* Device: Endovascular treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥ 18 years of age; Patients with ≥1 infrapopliteal artery disease (P3 popliteal artery, anterior tibial artery, posterior tibial artery, peroneal artery, tibiofibular trunk) need to receive endovascular treatment, regardless of whether there is a combination of supra-knee or submalleolar occlusion; Patients voluntary and capable of follow-up; Exclusion Criteria: Patients who are known to be allergic to heparin, aspirin, other antiplatelet drugs, contrast agents, etc., and those who are unable to undergo endovascular therapy for other reasons; Pregnant and lactating women; Patients with thromboangiitis obliterans；

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rutherford scale < 4<br> | Device: Endovascular treatment<br>* Endovascular treatment for infrapopliteal arterial disease.<br>|
| Rutherford scale 4-5<br> | Device: Endovascular treatment<br>* Endovascular treatment for infrapopliteal arterial disease.<br>|
| Rutherford scale 6<br> | Device: Endovascular treatment<br>* Endovascular treatment for infrapopliteal arterial disease.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from major adverse event rate | Major adverse events include Death, major amputation rates and clinical driven target lesion revascularization (CDTLR). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amputation-free survival | Freedom from death and major amputation | 12 months | 
| Survival | Freedom from all-cause mortality. | 12 months | 
| Freedom from major amputation | Freedom from major amputation | 12 months | 
| Freedom from CDTLR | Freedom from clinical driven target lesion revascularization | 12 months | 
| Freedom from clinical driven target limb revascularization | Freedom from clinical driven target limb revascularization | 12 months | 
| Rutherford categories | Rutherford categories | 12 months | 
| Wound condition | Wound and foot infections were scored using WIfI system. | 12 months | 
| Complication rates | Minor and Major complications rates. | 1 week | 
| Quality of life score | Vascular quality of life questionnaire was used. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endovascular Treatment, Infrapopliteal Artery Disease, Drug-coated Balloons, Angioplasty, Atherectomy