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

Xuanwu Hospital, Beijing842 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

842

Conditions

Chronic Limb-threatening Ischemia Endovascular Therapy

Interventions

Endovascular therapyDEVICE

Endovascular treatment for critical limb threatening Ischemia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. patients \> 18 years of age; 2. patients with Chronic limb-threatening ischemia (CLTI); 3. patients with below-the-knee lesions undergoing endovascular treatment; 4. target limbs with certain WIfI stage; 5. patients voluntary and capable of follow-up; 6. 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: 1. Contraindication for antiplatelet , anticoagulant or thrombolytic agent; 2. Contrast agent allergy; 3. Dysfunctional protein C, protein S, antithrombin Ⅲ(AT Ⅲ) or refusal of blood transfusion; 4. Complications affecting surgical safety; 5. Major amputation was adopted to the target extremity; 6. The existence of aneurysm in the target vessels; 7. The existence of perforation, dissection or any other injury requiring intervention in the target vessels.

Locations (1)

Xuanwu Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Freedom from major amputation

Major amputation was defined as any amputation above-the-ankle of the target limb.

Time frame: 12 months

Secondary Outcomes

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.

Time frame: 12 months

Amputation-free survival

Survival without target limb major amputation.

Time frame: 12 months

Freedom from all-cause death

Freedom from all-cause death.

Time frame: 12 months

Freedom from clinically driven target limb reintervention

Clinically driven target limb reintervention was defined as any reintervention of ipsilateral infrapopliteal arteries for recurrent clinical symptoms.

Time frame: 12 months

Freedom from major adverse event

Major adverse event was a composite of major amputation, all-cause death, and clinically driven target limb reintervention.

Time frame: 12 months

Quality of life

The Vascular Quality of Life (VascuQol) questionnaire was used to assess QOL score.

Time frame: 12 months

Primary sustained clinical improvement

A decrease of at least 1 Rutherford grade without any reintervention.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.