Results of Endovascular Treatment for Infrapopliteal Arterial Occlusive Disease: a Prospective, Multicenter, Real-world Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Freedom from major adverse event rate
研究概览
简要总结
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.
详细描述
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.
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 ≥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;
排除标准
- •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；
结局指标
主要结局
Freedom from major adverse event rate
时间窗: 12 months
Major adverse events include Death, major amputation rates and clinical driven target lesion revascularization (CDTLR).
次要结局
- Survival(12 months)
- Amputation-free survival(12 months)
- Freedom from major amputation(12 months)
- Freedom from CDTLR(12 months)
- Freedom from clinical driven target limb revascularization(12 months)
- Rutherford categories(12 months)
- Wound condition(12 months)
- Complication rates(1 week)
- Quality of life score(12 months)