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| Name | Class |
|---|---|
| Peking University Third Hospital | OTHER |
| Peking University First Hospital | OTHER |
| Beijing Hospital | OTHER_GOV |
| Chengdu University of Traditional Chinese Medicine |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rutherford scale < 4 |
| ||
| Rutherford scale 4-5 |
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| Rutherford scale 6 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular treatment | Device | Endovascular treatment for infrapopliteal arterial disease. |
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| Measure | Description | Time Frame |
|---|---|---|
| Freedom from major adverse event rate | Major adverse events include Death, major amputation rates and clinical driven target lesion revascularization (CDTLR). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Amputation-free survival | Freedom from death and major amputation | 12 months |
| Survival | Freedom from all-cause mortality. | 12 months |
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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 obliteransï¼›
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Patients with infrapopliteal arterial occlusive disease undergoing endovascular treatment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lianrui Guo, M.D. | Contact | +8613671009746 | lianruiguo@sina.com | |
| Xixiang Gao, M.D. | Contact | +8613581674309 | vascsurgeon@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Lianrui Guo, M.D. | Xuanwu Hospital, Beijing | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100053 | China |
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| OTHER |
| The First Affiliated Hospital of Dalian Medical University | OTHER |
| Huashan Hospital | OTHER |
| Shanghai Pudong Hospital | OTHER |
| Shanghai Zhongshan Hospital | OTHER |
| The First Affiliated Hospital of Guangzhou Medical University | OTHER |
| Changhai Hospital | OTHER |
| Hebei General Hospital | OTHER |
| Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology | OTHER |
| LanZhou University | OTHER |
| The Second Hospital University of South China | OTHER |
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | OTHER |
| The Affiliated Hospital of Qingdao University | OTHER |
| Qingdao Haici Hospital | OTHER |
| Beijing Tsinghua Changgeng Hospital | OTHER |
| First Hospital of Tsinghua University | OTHER |
| Shanxi Provincial People's Hospital | OTHER_GOV |
| Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | OTHER |
| RenJi Hospital | OTHER |
| The Luhe Teaching Hospital of the Capital Medical University | OTHER |
| Beijing Friendship Hospital | OTHER |
| Second Affiliated Hospital of Soochow University | OTHER |
| Tianjin First Central Hospital | OTHER |
| Tianjin Medical University General Hospital | OTHER |
| Renmin Hospital of Wuhan University | OTHER |
| First Affiliated Hospital Xi'an Jiaotong University | OTHER |
| First Affiliated Hospital of Xinjiang Medical University | OTHER |
| Zhejiang University | OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| Chinese Academy of Medical Sciences, Fuwai Hospital | OTHER |
| Xiyuan Hospital of China Academy of Chinese Medical Sciences | OTHER |
| Xiangya Hospital of Central South University | OTHER |
| First Affiliated Hospital of Chongqing Medical University | OTHER |
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| Freedom from major amputation | Freedom from major amputation | 12 months |
| Freedom from CDTLR | Freedom from clinical driven target lesion revascularization | 12 months |
| Freedom from clinical driven target limb revascularization | Freedom from clinical driven target limb revascularization | 12 months |
| Rutherford categories | Rutherford categories | 12 months |
| Wound condition | Wound and foot infections were scored using WIfI system. | 12 months |
| Complication rates | Minor and Major complications rates. | 1 week |
| Quality of life score | Vascular quality of life questionnaire was used. | 12 months |