Status:
COMPLETED
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
Lead Sponsor:
Xuanwu Hospital, Beijing
Collaborating Sponsors:
RenJi Hospital
Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
Conditions:
Chronic Limb-threatening Ischemia
Endovascular Therapy
Eligibility:
All Genders
18+ years
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-t...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- Contraindication for antiplatelet , anticoagulant or thrombolytic agent;
- Contrast agent allergy;
- Dysfunctional protein C, protein S, antithrombin Ⅲ(AT Ⅲ) or refusal of blood transfusion;
- Complications affecting surgical safety;
- Major amputation was adopted to the target extremity;
- The existence of aneurysm in the target vessels;
- The existence of perforation, dissection or any other injury requiring intervention in the target vessels.
Key Trial Info
Start Date :
December 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2024
Estimated Enrollment :
842 Patients enrolled
Trial Details
Trial ID
NCT04710420
Start Date
December 1 2020
End Date
June 30 2024
Last Update
July 9 2024
Active Locations (1)
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1
Xuanwu Hospital
Beijing, Beijing Municipality, China, 100053