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
- 招募中
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Freedom from clinically-driven TLR
研究概览
简要总结
This study is a prospective, multi-center, real world, observational study, which aims at evaluating the intermediate and long-term efficacy of endovascular treatment for TASC C&D aortoiliac occlusive disease .It is estimated that 800 subjects diagnosed with TASC C&D aortoiliac occlusive disease and receive endovascular treatments will be enrolled in nine centers from April 2021 to June 2027 nation-widely. All the subjects will be under follow-up for 60 months. There is no restriction on the endovascular techniques. The primary outcomes covers freedom from TLR at 60 months.
详细描述
In the past decade, endovascular treatment has become the first-line treatment for iliac artery occlusion, while Aorta - bilateral femoral artery bypass surgery is preferred for more complex iliac artery occlusion. However, recently, with advances in endovascular devices and techniques, endovascular interventions have gradually replaced open surgery in many clinical problems and have shown ideal safety and efficacy.
Currently, the optimal treatment for TASC, C&D iliac artery occlusion is controversial, mostly based on limited data from single centers and few large multicenter databases or registries. In addition, the long-term efficacy of stents implantation in iliac artery disease remind unknown and might be influenced by stent type and calcification. Therefore, the purpose of this study was to evaluate the long-term efficacy and safety of endovascular treatment for TASC, C&D iliac artery occlusion in a multicenter study.
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 grades 3-
- •Follow the follow-up arrangement.
- •Age: 18-80 years old.
- •The target lesions were in the lower abdominal aorta and/or the common iliac artery and/or the external iliac artery.
- •The stenosis degree ≥50%, or restenosis (received PTA or other adjuvant therapy, including bare or covers stents), or complete occlusion, or the presence of aortailiac artery thrombosis after PMT or CDT thrombus clearance, and then further endovascular therapy perfomred.
- •Signed informed consent.
排除标准
- •Known allergy to drugs used in this study, including antiplatelet or anticoagulant drugs, etc.
- •Allergy to iodine contrast agent allergy;
- •Coagulation dysfunction or hypercoagulability;
- •Breast-feeding or pregnant women;
- •Life expectancy < 24 months;
- •Body condition can not tolerate endovascular treatment;
- •Type 2B, type 3 lower limb ischemia patients
结局指标
主要结局
Freedom from clinically-driven TLR
时间窗: 60 months
CD-TLR was defined as any reintervention within the target lesion(s) because of recurrent symptoms. Freedom form CD-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
- Incidence of major adverse events.(1month, 3 months,6 months, 12 months ,24 months)
- Health economics evaluation(60 months)
- CD-TLR(1 month, 3 months, 6 months, 12 months, 24 months, 36 months)
- Technical success rate(30 days)
- Adverser events related to insufficient lower limb blood supply.(1 month, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months)
- Vascular quality of life questionnaire(VascuQol)(1 month, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months)