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

Capital Medical University

Status: Completed

Conditions: Chronic Limb-threatening Ischemia; Endovascular Therapy

Treatments: Device: Endovascular therapy

Study type: Observational

Funder types: Other

Identifiers

NCT04710420

PRIME-WIFI

Details and patient eligibility

About

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.

Enrollment: 842 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

842 participants in 4 patient groups

WIfI stage 1

Description:

Very low risk of amputation was determined according to the SVS WIfI classification system.

Treatment:

Device: Endovascular therapy

WIfI stage 2

Description:

Low risk of amputation was determined according to the SVS WIfI classification system.

Treatment:

Device: Endovascular therapy

WIfI stage 3

Description:

Moderate risk of amputation was determined according to the SVS WIfI classification system.

Treatment:

Device: Endovascular therapy

WIfI stage 4

Description:

High risk of amputation was determined according to the SVS WIfI classification system.

Treatment:

Device: Endovascular therapy