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| Name | Class |
|---|---|
| RenJi Hospital | OTHER |
| Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology | OTHER |
| Zhejiang University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WIfI stage 1 | Very low risk of amputation was determined according to the SVS WIfI classification system. |
| |
| WIfI stage 2 | Low risk of amputation was determined according to the SVS WIfI classification system. |
| |
| WIfI stage 3 | Moderate risk of amputation was determined according to the SVS WIfI classification system. |
| |
| WIfI stage 4 | High risk of amputation was determined according to the SVS WIfI classification system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular therapy | Device | Endovascular treatment for critical limb threatening Ischemia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from major amputation | Major amputation was defined as any amputation above-the-ankle of the target limb. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Amputation-free survival |
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Inclusion Criteria:
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:
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Patients with Chronic limb-threatening ischemia.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital | Beijing | Beijing Municipality | 100053 | China |
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| First Affiliated Hospital of Zhejiang University |
| OTHER |
| Second Affiliated Hospital of Soochow University | OTHER |
| Qingdao Haici Hospital | OTHER |
| Chengdu University of Traditional Chinese Medicine | OTHER |
| Fudan University | OTHER |
| Huashan Hospital | OTHER |
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Survival without target limb major amputation.
| 12 months |
| Freedom from all-cause death | Freedom from all-cause death. | 12 months |
| 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 |
| 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 |
| Quality of life | The Vascular Quality of Life (VascuQol) questionnaire was used to assess QOL score. | 12 months |
| Primary sustained clinical improvement | A decrease of at least 1 Rutherford grade without any reintervention. | 12 months |
| Hospitalization time | The length of hospital stay was evaluated | 12 months |
| Hospitalization expenses | Hospitalization costs for patients were evaluated | 12 months |
| Adverse event rates | Adverse event rates includes surgically related arterial dissection, perforation, rupture, embolism, acute thrombosis, pseudoaneurysm and hematoma formation | 1 week |
| ID | Term |
|---|---|
| D000089802 | Chronic Limb-Threatening Ischemia |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |
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