Results of Endovascular Treatment for Infrapopliteal Arterial Occlusive Disease.

Recruiting

• Conditions: Infrapopliteal Artery Occlusive Disease; Endovascular Treatment
• Interventions: Device: Endovascular treatment

• Registration Number: NCT06009146
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief Summary

This study is a prospective, multi-center observational study, which evaluates the effectiveness and safety of endovascular therapy in the real world for infrapopliteal arterial occlusive disease from intermittent claudication to chronic threatening limb ischemia.

Detailed Description

This study is a prospective, multi-center observational study. This study will be conducted at 38 centers and is expected to enroll more than 3000 patients. And we will evaluate the effectiveness and safety of endovascular therapy in the real world for infrapopliteal arterial occlusive disease from intermittent claudication to chronic threatening limb ischemia.

Study Timeline

• Study Start: 2023-07-01
• Status Verified: 2023-08
• Study First Submitted: 2023-08-20
• Study First Submitted QC: 2023-08-20
• Last Update Submitted: 2023-08-20
• Study First Posted: 2023-08-24
• Last Update Posted: 2023-08-24
• Primary Completion: 2024-10-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

Patients ≥ 18 years of age; Patients with ≥1 infrapopliteal artery disease (P3 popliteal artery, anterior tibial artery, posterior tibial artery, peroneal artery, tibiofibular trunk) need to receive endovascular treatment, regardless of whether there is a combination of supra-knee or submalleolar occlusion; Patients voluntary and capable of follow-up;

Exclusion Criteria

Patients who are known to be allergic to heparin, aspirin, other antiplatelet drugs, contrast agents, etc., and those who are unable to undergo endovascular therapy for other reasons; Pregnant and lactating women; Patients with thromboangiitis obliterans；

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rutherford scale < 4	Endovascular treatment	-
Rutherford scale 4-5	Endovascular treatment	-
Rutherford scale 6	Endovascular treatment	-

Primary Outcome Measures

Name	Time	Method
Freedom from major adverse event rate	12 months	Major adverse events include Death, major amputation rates and clinical driven target lesion revascularization (CDTLR).

Secondary Outcome Measures

Name	Time	Method
Amputation-free survival	12 months	Freedom from death and major amputation
Survival	12 months	Freedom from all-cause mortality.
Freedom from major amputation	12 months	Freedom from major amputation
Freedom from CDTLR	12 months	Freedom from clinical driven target lesion revascularization
Freedom from clinical driven target limb revascularization	12 months	Freedom from clinical driven target limb revascularization
Rutherford categories	12 months	Rutherford categories
Wound condition	12 months	Wound and foot infections were scored using WIfI system.
Complication rates	1 week	Minor and Major complications rates.
Quality of life score	12 months	Vascular quality of life questionnaire was used.

Trial Locations

Locations (1)

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China