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

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

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 Overview

• Status: Completed
• Conditions: Chronic Limb-threatening Ischemia; Endovascular Therapy
• Intervention / Treatment: Device: Endovascular therapy

• Study Type: Observational
• Enrollment (Actual): 842

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Xuanwu Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with Chronic limb-threatening ischemia.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
WIfI stage 1; Very low risk of amputation was determined according to the SVS WIfI classification system.	Device: Endovascular therapy; Endovascular treatment for critical limb threatening Ischemia
WIfI stage 2; Low risk of amputation was determined according to the SVS WIfI classification system.	Device: Endovascular therapy; Endovascular treatment for critical limb threatening Ischemia
WIfI stage 3; Moderate risk of amputation was determined according to the SVS WIfI classification system.	Device: Endovascular therapy; Endovascular treatment for critical limb threatening Ischemia
WIfI stage 4; High risk of amputation was determined according to the SVS WIfI classification system.	Device: Endovascular therapy; Endovascular treatment for critical limb threatening Ischemia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from major amputation	Major amputation was defined as any amputation above-the-ankle of the target limb.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization time	The length of hospital stay was evaluated	12 months
Hospitalization expenses	Hospitalization costs for patients were evaluated	12 months
Adverse event rates	Adverse event rates includes surgically related arterial dissection, perforation, rupture, embolism, acute thrombosis, pseudoaneurysm and hematoma formation	1 week
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
Amputation-free survival	Survival without target limb major amputation.	12 months
Freedom from all-cause death	Freedom from all-cause death.	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.	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.	12 months
Quality of life	The Vascular Quality of Life (VascuQol) questionnaire was used to assess QOL score.	12 months
Primary sustained clinical improvement	A decrease of at least 1 Rutherford grade without any reintervention.	12 months

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Collaborators: Fudan University; RenJi Hospital; Huashan Hospital; First Affiliated Hospital of Zhejiang University; Zhejiang University; Second Affiliated Hospital of Soochow University; Qingdao Haici Hospital; Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology; Hospital of Chengdu University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: January 8, 2021
• First Submitted That Met QC Criteria: January 12, 2021
• First Posted (Actual): January 14, 2021

Study Record Updates

• Last Update Posted (Actual): July 9, 2024
• Last Update Submitted That Met QC Criteria: July 8, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Disease Attributes; Atherosclerosis; Peripheral Vascular Diseases; Chronic Disease; Peripheral Arterial Disease; Ischemia; Chronic Limb-Threatening Ischemia
• Other Study ID Numbers: PRIME-WIFI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes