Prospective Multicenter Registry on the Endovascular Treatment in Critical Limb Threatening Ischemia With Below the Knee Lesions With Wound, Ischemia, and Foot Infection (WIFI) Assessment

Study Overview
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Brief Summary
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This is a prospective multicenter clinical study that used WIFI grading scores at different periods to evaluate the therapeutic value of endovascular therapy and this grading system for Chronic limb-threatening ischemia.

Official Title
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Prospective Multicenter Registry on the Endovascular Treatment in Critical Limb Threatening Ischemia With Below the Knee Lesions With WIFI Assessment

Conditions
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Chronic Limb-threatening Ischemia, Endovascular Therapy

Intervention / Treatment
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* Device: Endovascular therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients > 18 years of age; patients with Chronic limb-threatening ischemia (CLTI); patients with below-the-knee lesions undergoing endovascular treatment; target limbs with certain WIfI stage; patients voluntary and capable of follow-up; informed consent. Definition of CLTI: A diagnosis of CLTI requires objectively documented atherosclerotic PAD in association with ischemic rest pain or tissue loss (ulceration or gangrene). Exclusion Criteria: Contraindication for antiplatelet , anticoagulant or thrombolytic agent; Contrast agent allergy; Dysfunctional protein C, protein S, antithrombin Ⅲ(AT Ⅲ) or refusal of blood transfusion; Participation in other clinical study; Complications affecting surgical safety; Major amputation was adopted to the target extremity; The existence of aneurysm in the target vessels; The existence of perforation, dissection or any other injury requiring intervention in the target vessels.

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 |
| --- | --- |
| WIfI stage 1<br>Very low risk of amputation was determined according to the SVS WIfI classification system. | Device: Endovascular therapy<br>* Endovascular treatment for critical limb threatening Ischemia<br>|
| WIfI stage 2<br>Low risk of amputation was determined according to the SVS WIfI classification system. | Device: Endovascular therapy<br>* Endovascular treatment for critical limb threatening Ischemia<br>|
| WIfI stage 3<br>Moderate risk of amputation was determined according to the SVS WIfI classification system. | Device: Endovascular therapy<br>* Endovascular treatment for critical limb threatening Ischemia<br>|
| WIfI stage 4<br>High risk of amputation was determined according to the SVS WIfI classification system. | Device: Endovascular therapy<br>* Endovascular treatment for critical limb threatening Ischemia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The composite end point | Death, major amputation rates and clinical driven target lesion revascularization (CDTLR) | 12 months | 
| WIfI stages | Before follow-up and during each follow-up, the Society for Vascular Surgery wound, ischemia, and foot Infection (WIfI) were evaluated classification system | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event rates | Adverse event rates includes surgically related arterial dissection, perforation, rupture, embolism, acute thrombosis, pseudoaneurysm and hematoma formation | 1 week | 
| Rutherford categories | Rutherford categories were evaluated | 12 months | 
| ABI | Ankle brachial index was evaluated | 12 months | 
| TcPO2 | Transcutaneous pressure of oxygen was evaluated | 12 months | 
| Wagner's grades | For Rutherford categories from 5 to 6, the Wagner's grades ranges from 0 to 5, grade 5 means the worst | 12 months | 
| Hospitalization time | The length of hospital stay was evaluated | 12 months | 
| Hospitalization expenses | Hospitalization costs for patients were evaluated | 12 months |