NCT05856344

A Study for Crossability of Spherical Tip Versus Regular Noncompliant Balloon in Tortuous Coronary Artery Postdilatation

A Study for Crossability of Novel Spherical Tip Versus Regular Noncompliant Balloon in Tortuous Coronary Artery Postdilatation：A Multicenter, Randomized, Controlled, Single Blind Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: First Hospital of China Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Spherical tip noncompliant balloon	The main difference of this experimental balloon is the spherical tip, other parameters are consistent with regular noncompliant balloons.
DEVICE	Regular noncompliant balloon	The balloon is designed as tapered-tip.

Timeline

• Start date: 2023-02-20
• Primary completion: 2024-08-27
• Completion: 2024-12-01
• First posted: 2023-05-12
• Last updated: 2025-01-14

Locations

1 site across 1 country: China