Intermediate and Long-term Efficacy of Endovascular Treatment for TASC C&D Aortoiliac Occlusive Disease: a Prospective, Multicenter, Real-world, Registry Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 800
- 主要终点
- Free from clinically-drived target lesion reintervention
研究概览
简要总结
This is a prospective, multicenter, real-world, registry study, which aims to observe the intermediate and long-term efficacy of different endovascular treatments for TASC C&D aortoiliac occlusive disease.
详细描述
Currently, the optimal therapy for TASC C and D type aortic occlusive disease is still controversial. The evidence comes from several singe-center studies with small sample size. In addition, the long-term efficacy of stent implantation and drug coated device in aortic occlusive disease remains unclear, which might be affected by the type of stent and calcification extent. Thus, this study aims to observe the intermediate and long-term efficacy of different endovascular treatments for TASC C&D aortoiliac occlusive disease in multiple centers.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rutherford classification of 3-6
- •Willing to comply with all follow-up evaluations at the specified times
- •Target lesion(s) located within the native infrarenal abdominal aorta and/or common iliac artery and/or external iliac artery
- •Evidence of ≥ 50% stenosis, restenosis (from PTA or adjunct therapy, not including stents or stent grafts), or occlusion of target lesion(s), or arterial thrombosis underwent PMT or CDT
- •Provides written informed consent
排除标准
- •Contraindication or known untreatable allergy to antiplatelet therapy, anticoagulants, thrombolytic drugs, or any other drug used during the study
- •Known hypersensitivity to contrast material that cannot be adequately pretreated
- •Bleeding diathesis or coagulopathy, known hypercoagulable condition or refuses blood transfusion
- •Female currently breastfeeding, pregnant, or of childbearing potential not using adequate contraceptive measures
- •Life expectancy less than 24 months
- •Current participation in an investigational drug or other device study
- •Severe comorbid conditions
- •Myocardial infarction or stroke within 3 months prior to enrollment
结局指标
主要结局
Free from clinically-drived target lesion reintervention
时间窗: 5 years
TLR was defined as a reintervention performed for \>50% diameter stenosis or in the target lesion after documentation of recurrent clinical symptoms following the index procedure or bailout stenting during the index procedure. Freedom form TLR were defined as the rates of the number of patients who did not receive reintervention verse the number of patients during the follow-up period.
次要结局
- Primary patency rate(6 months, 1 year, 2 years, 3 years, 4 years, 5 years)
- Incidence of adverse blood supply events(6 months, 1 year, 2 years, 3 years, 4 years, 5 years)
- Vascular quality of life questionnaire(VascuQol)(6 months, 1 year, 2 years, 3 years, 4 years, 5 years)
- Total Cost of treatment(3 years, 5 years)
- Technique success rate(30 days)
- Perioperative adverse events(30 days)