A Study for Crossability of Novel Spherical Tip Versus Regular Noncompliant Balloon in Tortuous Coronary Artery Postdilatation：A Multicenter, Randomized, Controlled, Single Blind Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Success passage rate at the first attempt
研究概览
简要总结
The goal of this clinical trial is to compare the crossability of novel spherical tip versus regular noncompliant balloon in CHD population with tortuous coronary artery leisions that requiring postdilation after stent implantation.
The main question it aims to answer is:
•Wether the spherical tip balloon have advantages in terms of crossability compared to regular noncompliant balloons Participants will sign an informed consent form, collaborate with data collection, and accept the intervention measures from corresponding groups. Researchers will compare spherical tip balloon with regular noncompliant balloon to see if there is any difference in crossability.
详细描述
The tortuous lesion increases the difficulty of coronary intervention treatment, especially when there is still a large angle after stent implantation. The ability of the non compliant balloon to pass through the stent segment becomes the key to complete the operation.
The spherical tip noncompliant balloon is an original design by our center, which reduces its resistance to stent struts through the spherical structure of balloon tip, and is committed to increasing the crossability of the balloon.This study is a multicenter, randomized, single blind design with the aim of truly revealing the differences in parameters such as success rate of crossing, times of attemptation, and time consumption between the novel spherical tip and regular non compliant balloon.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Over 18 years old, regardless of gender
- •Patients with indications for coronary artery stent implantation
- •The vascular curvature angle<120 ° after coronary artery stent implantation
- •Noncompliant balloon postdilation is required
- •Voluntarily participate and sign an informed consent form
排除标准
- •Pregnant women or patients who are attempting to get pregnant
- •Patients participating in clinical trials of other drugs or medical devices
- •Patients deemed unsuitable by the researchers to participate in this clinical trial
结局指标
主要结局
Success passage rate at the first attempt
时间窗: From start to end of surgery
The success passage rate of the noncompliant balloon through the tortuous target lesion at the first attempt
次要结局
- Major adverse cardiac event(3 months after percutaneous coronary intervention)
- The final success passage rate(From start to end of surgery)
- The number of attempts(From start to end of surgery)
- The time required(From start to end of surgery)
研究者
Yingxian Sun
Chief of Department of Cardiology in First Hospital of China Medical University
First Hospital of China Medical University