Clinical trial NCT04710420: 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
Official title: Prospective Multicenter Registry on the Endovascular Treatment in Critical Limb Threatening Ischemia With Below the Knee Lesions With WIFI Assessment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Limb-threatening Ischemia
Endovascular Therapy
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: RenJi Hospital
name: Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
name: Zhejiang University
name: First Affiliated Hospital of Zhejiang University
name: Second Affiliated Hospital of Soochow University
name: Qingdao Haici Hospital
name: Hospital of Chengdu University of Traditional Chinese Medicine
name: Fudan University
name: Huashan Hospital
First posted: 2021-01-14
Enrollment: 842
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Chronic limb-threatening ischemia.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Freedom from major amputation
timeFrame: 12 months
Secondary outcomes:
measure: WIfI stages
timeFrame: 12 months
measure: Amputation-free survival
timeFrame: 12 months
measure: Freedom from all-cause death
timeFrame: 12 months
measure: Freedom from clinically driven target limb reintervention
timeFrame: 12 months
measure: Freedom from major adverse event
timeFrame: 12 months
measure: Quality of life
timeFrame: 12 months
measure: Primary sustained clinical improvement
timeFrame: 12 months
measure: Hospitalization time
timeFrame: 12 months
measure: Hospitalization expenses
timeFrame: 12 months
measure: Adverse event rates
timeFrame: 1 week
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital
state: Beijing
Study officials:
References: