Endovascular Treatment, Infrapopliteal Artery Occlusive Disease
Conditions
Keywords
Endovascular Treatment, Infrapopliteal Artery Disease, Drug-coated Balloons, Angioplasty, Atherectomy
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.
Interventions
DEVICEEndovascular treatment
Endovascular treatment for infrapopliteal arterial disease.
Sponsors
Peking University Third Hospital
Peking University First Hospital
Beijing Hospital
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
Xuanwu Hospital, Beijing
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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；
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from major adverse event rate | 12 months | Major adverse events include Death, major amputation rates and clinical driven target lesion revascularization (CDTLR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Amputation-free survival | 12 months | Freedom from death and major amputation |
| 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. |
| Rutherford categories | 12 months | Rutherford categories |
Countries
China
Contacts
Primary ContactLianrui Guo, M.D.
Backup ContactXixiang Gao, M.D.
Outcome results
None listed