Results of Endovascular Treatment for Infrapopliteal Arterial Occlusive Disease.

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ClinicalTrials.gov Identifier: NCT06009146

Recruitment Status : Recruiting

First Posted : August 24, 2023

Last Update Posted : August 24, 2023

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View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborators:

Peking University Third Hospital

Peking University First Hospital

Beijing Hospital

Hospital of Chengdu University of Traditional Chinese Medicine

The First Affiliated Hospital of Dalian Medical University

Huashan Hospital

Shanghai Pudong Hospital

Shanghai Zhongshan Hospital

The First Affiliated Hospital of Guangzhou Medical University

Changhai Hospital

Hebei General Hospital

Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology

LanZhou University

The Second Hospital University of South China

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

The Affiliated Hospital of Qingdao University

Qingdao Haici Hospital

Beijing Tsinghua Changgeng Hospital

First Hospital of Tsinghua University

Shanxi Provincial People's Hospital

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

RenJi Hospital

The Luhe Teaching Hospital of the Capital Medical University

Beijing Friendship Hospital

Second Affiliated Hospital of Soochow University

Tianjin First Central Hospital

Tianjin Medical University General Hospital

Renmin Hospital of Wuhan University

First Affiliated Hospital Xi'an Jiaotong University

First Affiliated Hospital of Xinjiang Medical University

Zhejiang University

The First Affiliated Hospital of Zhengzhou University

Chinese Academy of Medical Sciences, Fuwai Hospital

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Xiangya Hospital of Central South University

First Affiliated Hospital of Chongqing Medical University

Information provided by (Responsible Party):

Xuanwu Hospital, Beijing

Study Description

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.

Condition or disease	Intervention/treatment
Infrapopliteal Artery Occlusive Disease Endovascular Treatment	Device: Endovascular treatment

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 Design

Layout table for study information

Study Type :	Observational
Estimated Enrollment :	3000 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Results of Endovascular Treatment for Infrapopliteal Arterial Occlusive Disease: a Prospective, Multicenter, Real-world Study
Actual Study Start Date :	July 1, 2023
Estimated Primary Completion Date :	October 1, 2024
Estimated Study Completion Date :	October 1, 2025

Groups and Cohorts

Group/Cohort	Intervention/treatment
Rutherford scale < 4	Device: Endovascular treatment Endovascular treatment for infrapopliteal arterial disease.
Rutherford scale 4-5	Device: Endovascular treatment Endovascular treatment for infrapopliteal arterial disease.
Rutherford scale 6	Device: Endovascular treatment Endovascular treatment for infrapopliteal arterial disease.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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Layout table for eligibility information

Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with infrapopliteal arterial occlusive disease undergoing endovascular treatment.

Criteria

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；

Contacts and Locations