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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
250
The main difference of this experimental balloon is the spherical tip, other parameters are consistent with regular noncompliant balloons.
The balloon is designed as tapered-tip.
First Hospital of China Medical University
Shenyang, Liaoning, China
Success passage rate at the first attempt
The success passage rate of the noncompliant balloon through the tortuous target lesion at the first attempt
Time frame: From start to end of surgery
The final success passage rate
The final success passage rate of the noncompliant balloon through the tortuous target lesion under three attempts
Time frame: From start to end of surgery
The number of attempts
The number of attempts required for the noncompliant balloon to pass through the tortuous target lesion
Time frame: From start to end of surgery
The time required
The time required for the noncompliant balloon to pass through the tortuous target lesion
Time frame: From start to end of surgery
Major adverse cardiac event
defined as death from all, cardiac, or noncardiac causes, myocardial infarction, repeat revascularization and stroke during follow-up
Time frame: 3 months after percutaneous coronary intervention
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