NCT05894460招募中不适用
Constrained Balloon Combined With Drug-coated Balloon Angioplasty for Femoropopliteal Lesion: a Single-centre, Prospective Observational Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 254
- 试验地点
- 1
- 主要终点
- Primary patency
研究概览
简要总结
This study will assess the safety and efficacy of Chocolate balloons as a combination with drug-coated balloons in the treatment of popliteal artery lesions in lower limb atherosclerotic occlusive disease and will compare them with conventional balloons.
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
- •Rutherford classification of 2-6 in patients with femoropopliteal atherosclerotic occlusive disease;
- •primary cases with no previous surgical treatment of the target lesion;
- •presence of at least one vessel with patency in the distal outflow tract;
- •survival >1 year.
排除标准
- •planned stenting;
- •presence of flow-limiting dissection prior to application of Chocolate balloon and conventional balloon dilation of the target lesion;
- •combination of severe organ dysfunction of the heart, lungs and brain that cannot tolerate the procedure;
- •allergy to contrast agents, anaesthetic drugs, anticoagulants and anti-platelet drugs;
- •ineffective recanalization attempts;
- •lesions within or adjacent to the aneurysm, or the presence of a popliteal aneurysm.
结局指标
主要结局
Primary patency
时间窗: 12 months
No occlusion or restenosis (\>50%) of the target vessel in the treated segment during follow-up and no further intervention is required.
次要结局
未报告次要终点
研究者
研究点 (1)
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