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

Completed

• Conditions: Endovascular Therapy; Chronic Limb-threatening Ischemia
• Interventions: Device: Endovascular therapy

• Registration Number: NCT04710420
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2021-01-08
• Study First Submitted QC: 2021-01-12
• Study First Posted: 2021-01-14
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-08
• Last Update Posted: 2024-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 842

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
WIfI stage 1	Endovascular therapy	Very low risk of amputation was determined according to the SVS WIfI classification system.
WIfI stage 4	Endovascular therapy	High risk of amputation was determined according to the SVS WIfI classification system.
WIfI stage 3	Endovascular therapy	Moderate risk of amputation was determined according to the SVS WIfI classification system.
WIfI stage 2	Endovascular therapy	Low risk of amputation was determined according to the SVS WIfI classification system.

Primary Outcome Measures

Name	Time	Method
Freedom from major amputation	12 months	Major amputation was defined as any amputation above-the-ankle of the target limb.

Secondary Outcome Measures

Name	Time	Method
Freedom from major adverse event	12 months	Major adverse event was a composite of major amputation, all-cause death, and clinically driven target limb reintervention.
Adverse event rates	1 week	Adverse event rates includes surgically related arterial dissection, perforation, rupture, embolism, acute thrombosis, pseudoaneurysm and hematoma formation
WIfI stages	12 months	Before follow-up and during each follow-up, the Society for Vascular Surgery wound, ischemia, and foot Infection (WIfI) were evaluated classification system.
Freedom from all-cause death	12 months	Freedom from all-cause death.
Hospitalization time	12 months	The length of hospital stay was evaluated
Amputation-free survival	12 months	Survival without target limb major amputation.
Freedom from clinically driven target limb reintervention	12 months	Clinically driven target limb reintervention was defined as any reintervention of ipsilateral infrapopliteal arteries for recurrent clinical symptoms.
Quality of life	12 months	The Vascular Quality of Life (VascuQol) questionnaire was used to assess QOL score.
Primary sustained clinical improvement	12 months	A decrease of at least 1 Rutherford grade without any reintervention.
Hospitalization expenses	12 months	Hospitalization costs for patients were evaluated

Trial Locations

Locations (1)

Xuanwu Hospital; 🇨🇳 Beijing, Beijing, China