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

NCT04710420 | Completed FDA Device

• 1 other identifier: PRIME-WIFI
• Study Type: observational
• Target: 842
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Limb-threatening Ischemia; Endovascular Therapy

Outcome Measures

Primary Outcomes (1)

• Freedom from major amputation

  Major amputation was defined as any amputation above-the-ankle of the target limb.

  12 months

Secondary Outcomes (10)

• WIfI stages

  12 months

• Amputation-free survival

  12 months

• Freedom from all-cause death

  12 months

• Freedom from clinically driven target limb reintervention

  12 months

• Freedom from major adverse event

  12 months

Study Arms (4)

WIfI stage 1

Very low risk of amputation was determined according to the SVS WIfI classification system.

Device: Endovascular therapy

WIfI stage 2

Low risk of amputation was determined according to the SVS WIfI classification system.

Device: Endovascular therapy

WIfI stage 3

Moderate risk of amputation was determined according to the SVS WIfI classification system.

Device: Endovascular therapy

WIfI stage 4

High risk of amputation was determined according to the SVS WIfI classification system.

Device: Endovascular therapy

Interventions

Endovascular therapy DEVICE

Endovascular treatment for critical limb threatening Ischemia

WIfI stage 1; WIfI stage 2; WIfI stage 3; WIfI stage 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Chronic limb-threatening ischemia.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Xuanwu Hospital

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, vascular suregry department

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: January 14, 2021
• Study Start: December 1, 2020
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: July 9, 2024

Record last verified: 2024-07

Locations

CN (1)