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
NCT ID: NCT04710420
Last Updated: 2024-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
842 participants
OBSERVATIONAL
2020-12-01
2024-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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WIfI stage 1
Very low risk of amputation was determined according to the SVS WIfI classification system.
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.
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.
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.
Endovascular therapy
Endovascular treatment for critical limb threatening Ischemia
Interventions
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Endovascular therapy
Endovascular treatment for critical limb threatening Ischemia
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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RenJi Hospital
OTHER
Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
OTHER
Zhejiang University
OTHER
First Affiliated Hospital of Zhejiang University
OTHER
Second Affiliated Hospital of Soochow University
OTHER
Qingdao Haici Hospital
OTHER
Hospital of Chengdu University of Traditional Chinese Medicine
UNKNOWN
Fudan University
OTHER
Huashan Hospital
OTHER
Xuanwu Hospital, Beijing
OTHER
Responsible Party
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Lian-Rui Guo
Director, vascular suregry department
Locations
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Xuanwu Hospital
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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PRIME-WIFI
Identifier Type: -
Identifier Source: org_study_id
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