NCT04710420已完成不适用
Prospective Multicenter Registry on the Endovascular Treatment in Critical Limb Threatening Ischemia With Below the Knee Lesions With WIFI Assessment
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 842
- 试验地点
- 1
- 主要终点
- Freedom from major amputation
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients > 18 years of age;
- •patients with Chronic limb-threatening ischemia (CLTI);
- •patients with below-the-knee lesions undergoing endovascular treatment;
- •target limbs with certain WIfI stage;
- •patients voluntary and capable of follow-up;
- •informed consent.
- •Definition of CLTI:
- •A diagnosis of CLTI requires objectively documented atherosclerotic PAD in association with ischemic rest pain or tissue loss (ulceration or gangrene).
排除标准
- •Contraindication for antiplatelet , anticoagulant or thrombolytic agent;
- •Contrast agent allergy;
- •Dysfunctional protein C, protein S, antithrombin Ⅲ(AT Ⅲ) or refusal of blood transfusion;
- •Complications affecting surgical safety;
- •Major amputation was adopted to the target extremity;
- •The existence of aneurysm in the target vessels;
- •The existence of perforation, dissection or any other injury requiring intervention in the target vessels.
结局指标
主要结局
Freedom from major amputation
时间窗: 12 months
Major amputation was defined as any amputation above-the-ankle of the target limb.
次要结局
- Freedom from major adverse event(12 months)
- Adverse event rates(1 week)
- WIfI stages(12 months)
- Freedom from all-cause death(12 months)
- Hospitalization time(12 months)
- Amputation-free survival(12 months)
- Freedom from clinically driven target limb reintervention(12 months)
- Quality of life(12 months)
- Primary sustained clinical improvement(12 months)
- Hospitalization expenses(12 months)
研究者
Lian-Rui Guo
Director, vascular suregry department
Xuanwu Hospital, Beijing
研究点 (1)
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