NCT05552911招募中不适用
Clinical Prognosis and Influencing Factors of Drug-coated Balloon Therapy in Patients With Coronary In-stent Restenosis and de Novo Coronary Lesions
The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2022年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- LLL of 12±3 months after surgery
研究概览
简要总结
This was a single-center, prospective, open-label, observational study. Patients with coronary artery disease confirmed by coronary angiography and treated with drug-coated balloon catheter alone for target vessels were enrolled in the Cardiology Department of our hospital in January 2022. The primary endpoint was late lumen loss within 12±3 months after surgery.
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 aged ≥18 years with coronary heart disease;
- •If the target lesion stenosis ≥70% is complicated with angina pectoris or evidence of myocardial ischemia, DCB should be administered;
- •Residual lumen diameter stenosis ≤30% after lesion pretreatment and DCB, no vessel dissection, or type A or B dissection, and TIMI blood flow level 3;
- •Target lesions were treated with DCB for the first time.
排除标准
- •Intraoperative implantation of salvage stent in DCB;
- •Acute myocardial infarction occurred within 1 week after DCB operation;
- •Less than 3 months of dual antiplatelet therapy after DCB operation, or more than 1 month of discontinuation of antiplatelet therapy;
- •The position of the stent could not be determined by coronary angiography.
- •Desmovascular disease or left main artery disease;
- •Atrial fibrillation;
- •Patients with severe heart failure, valvular heart disease, renal insufficiency, severe infection and autoimmune disease.
结局指标
主要结局
LLL of 12±3 months after surgery
时间窗: 12±3 months after surgery
Late lumen loss of 12±3 months after surgery
次要结局
- MACE event 12 months after surgery(12 months after surgery)
研究者
Chunjian Li
Department of cardiovascular, Director of CCU
The First Affiliated Hospital with Nanjing Medical University
研究点 (1)
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