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

Chronic Limb-threatening Ischemia Clinical Trial

Official title:

Prospective Multicenter Registry on the Endovascular Treatment in Critical Limb Threatening Ischemia With Below the Knee Lesions With WIFI Assessment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04710420
• Other study ID #: PRIME-WIFI
• Status: Completed
• Start date: December 1, 2020
• Est. completion date: February 29, 2024

Study information

• Verified date: April 2024
• Source: Xuanwu Hospital, Beijing
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 842
• Est. completion date: February 29, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ?(AT ?) 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.

Related Conditions & MeSH terms

• Chronic Limb-threatening Ischemia
• Endovascular Therapy
• Ischemia

Intervention

Device:
• Endovascular therapy
Endovascular treatment for critical limb threatening Ischemia

Locations

Country	Name	City	State
China	Xuanwu Hospital	Beijing	Beijing

Sponsors (10)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from major amputation	Major amputation was defined as any amputation above-the-ankle of the target limb.	12 months
Secondary	WIfI stages	Before follow-up and during each follow-up, the Society for Vascular Surgery wound, ischemia, and foot Infection (WIfI) were evaluated classification system.	12 months
Secondary	Amputation-free survival	Survival without target limb major amputation.	12 months
Secondary	Freedom from all-cause death	Freedom from all-cause death.	12 months
Secondary	Freedom from clinically driven target limb reintervention	Clinically driven target limb reintervention was defined as any reintervention of ipsilateral infrapopliteal arteries for recurrent clinical symptoms.	12 months
Secondary	Freedom from major adverse event	Major adverse event was a composite of major amputation, all-cause death, and clinically driven target limb reintervention.	12 months
Secondary	Quality of life	The Vascular Quality of Life (VascuQol) questionnaire was used to assess QOL score.	12 months
Secondary	Primary sustained clinical improvement	A decrease of at least 1 Rutherford grade without any reintervention.	12 months
Secondary	Hospitalization time	The length of hospital stay was evaluated	12 months
Secondary	Hospitalization expenses	Hospitalization costs for patients were evaluated	12 months
Secondary	Adverse event rates	Adverse event rates includes surgically related arterial dissection, perforation, rupture, embolism, acute thrombosis, pseudoaneurysm and hematoma formation	1 week