NCT05747287已完成不适用
A Post-Market Study to Evaluate the Safety and Efficacy of Pronavi Microcatheter for Use in Endovascular Interventions
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Technical success
研究概览
简要总结
This is a prospective, multi-center, single-group post-market study. It is planned to be carried out in about 3 clinical institutions, and a total of 60 subjects are expected to be enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age ≥ 18 years old;
- •Patients with symptomatic ischemic heart disease who are suitable for non-acute percutaneous coronary intervention (PCI);
- •Patients with target lesion diameter stenosis ≥ 70% (visually) or de novo coronary chronic total occlusion (CTO), or tortuous lesions, who plan to use Pronavi Microcatheter;
- •Patients or their guardians who understand the purpose of the trial, voluntarily participate and sign the written informed consent, and are able to be followed up.
排除标准
- •Patients with clinical symptoms consistent with ST-elevation myocardial infarction and/or ECG changes within 12 hours before the procedure;
- •Patients who are known to be intolerant to antiplatelet drugs or allergic to contrast media;
- •Patients with in-stent occlusion;
- •Patients with unprotected left main coronary artery disease;
- •Women who are pregnant or lactating;
- •Patients who are participating in clinical trials of other drugs or medical devices;
- •Patients with contraindications to the investigational device;
- •Other patients considered by the investigators to be unsuitable for this trial.
结局指标
主要结局
Technical success
时间窗: 0 day
Defined as successful guide wire passage, that is, the Pronavi Microcatheter successfully supports the guide wire through the target lesion to reach the distal true coelom.
次要结局
- Device super-selective angiography (if applicable)(0 day)
- Device success(0 day)
- Guide wire exchange supported (if applicable)(0 day)
- Procedural success(0 - 7 days)
- Device Performance Evaluation(0 day)
研究者
研究点 (3)
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