SeQuent Please Neo Multicenter Registry / Registro Multicéntrico Sequent Please NEO
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Target Lesion Revascularization (TLR) with clinical follow-up at 12 months.
研究概览
简要总结
The registry evaluates the safety and efficacy of paclitaxel-releasing SeQuent® Please Neo balloon in the following scenarios: restenosis, bifurcation lesions, small vessel lesions, diabetes (diffuse disease) and atrial fibrillation. The objective is to determine the success of the procedure and the preservation of vascular permeability.
详细描述
The preset registry aim is to evaluate the safety and efficacy of paclitaxel-releasing SeQuent® Please Neo balloon in the following scenarios: restenosis, bifurcation lesions, small vessel lesions, diabetes (diffuse disease) and atrial fibrillation. The principal objective is to determine the success of the procedure and the preservation of vascular permeability.
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
- 是
入选标准
- •ISR in a coronary artery with a diameter stenosis of at least 70%, a length of the stented segment of <25 mm, and a vascular diameter of at least 2.5 and up to 3.5 mm
排除标准
- •There is no exclusion criteria except those patients with contraindication for antiplatelet therapy.
结局指标
主要结局
Target Lesion Revascularization (TLR) with clinical follow-up at 12 months.
时间窗: From baseline to 12 months
Target Lesion Revascularization (TLR) with clinical follow-up at 12 months.
次要结局
- Acute adverse cardiac events rate (MACE) and and MACE rate accumulated at 12 months.(From baseline to 12 months)
- Premature follow-up indication(From baseline to 12 months)
- Success of balloon dilation.(Baseline)