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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05856344
• Other study ID #: [2023]25
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2023
• Est. completion date: November 15, 2023

Study information

• Verified date: May 2023
• Source: First Hospital of China Medical University
• Contact: Guozhe Sun, Phd
• Phone: 15040292137
• Email: gzhsun66[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 236
• Est. completion date: November 15, 2023
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Spherical tip noncompliant balloon
The main difference of this experimental balloon is the spherical tip, other parameters are consistent with regular noncompliant balloons.
• Regular noncompliant balloon
The balloon is designed as tapered-tip.

Locations

Country	Name	City	State
China	First Hospital of China Medical University	Shenyang	Liaoning

Sponsors (2)

Lead Sponsor	Collaborator
First Hospital of China Medical University	The People's Hospital of Liaoning Province

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success passage rate at the first attempt	The success passage rate of the noncompliant balloon through the tortuous target lesion at the first attempt	From start to end of surgery
Secondary	The final success passage rate	The final success passage rate of the noncompliant balloon through the tortuous target lesion under three attempts	From start to end of surgery
Secondary	The number of attempts	The number of attempts required for the noncompliant balloon to pass through the tortuous target lesion	From start to end of surgery
Secondary	The time required	The time required for the noncompliant balloon to pass through the tortuous target lesion	From start to end of surgery