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
Key facts
- Who runs it
- Xuanwu Hospital, Beijing
- Where
- China1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 842 people enrolled
- Started
- 1 Dec 2020
- Ended
- 30 Jun 2024
- Type of study
- Observational, 4 groups
- Treatments tested
- Endovascular therapy
- Record updated
- 9 July 2024
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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)
Who cannot take part
- Complications affecting surgical safety
- Contrast agent allergy
- The existence of perforation, dissection or any other injury requiring intervention in the target vessels
- Contraindication for antiplatelet , anticoagulant or thrombolytic agent
- Dysfunctional protein C, protein S, antithrombin Ⅲ(AT Ⅲ) or refusal of blood transfusion
- Major amputation was adopted to the target extremity
- The existence of aneurysm in the target vessels
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 4 groups in the trial
- WIfI stage 1
Very low risk of amputation was determined according to the SVS WIfI classification system.
Treatment: Endovascular therapy
- WIfI stage 2
Low risk of amputation was determined according to the SVS WIfI classification system.
Treatment: Endovascular therapy
- WIfI stage 3
Moderate risk of amputation was determined according to the SVS WIfI classification system.
Treatment: Endovascular therapy
- WIfI stage 4
High risk of amputation was determined according to the SVS WIfI classification system.
Treatment: Endovascular therapy
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Prospective Multicenter Registry on the Endovascular Treatment in Critical Limb Threatening Ischemia With Below the Knee Lesions With WIFI Assessment
- Record updated
- 9 July 2024