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

NCT ID: NCT05856344

Last Updated: 2025-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-20
• Study Completion Date: 2024-12-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Spherical tip noncompliant balloon

Enrolled patients who were randomly assigned to this group underwent stent postdilation using the spherical tip non compliant balloon(APT Medical Inc，CONQUEROR NC Pro). The selection of balloon size is based on the expected target lesion stent diameter, and the length range is restricted among 8-12mm. It will be defined as balloon passage failure if it fails to pass the target lesion after three attempts. After that, based on the purpose of completing the surgery, alternative options can be selected based on the surgeon's experience, including double-guide wire assistance, 5in6 support, the use of regular noncompliant balloon and so on.

Group Type: EXPERIMENTAL

Spherical tip noncompliant balloon

Intervention Type: DEVICE

The main difference of this experimental balloon is the spherical tip, other parameters are consistent with regular noncompliant balloons.

Regular noncompliant balloon

Enrolled patients who were randomly assigned to this group underwent stent postdilation using the regular noncompliant balloon(tapered-tip). The selection of balloon size is also based on the expected target lesion stent diameter, and the length range is restricted among 8-12mm. It will be defined as balloon passage failure if it fails to pass the target lesion after three attempts. After that, based on the purpose of completing the surgery, alternative options can be selected based on the surgeon's experience, including tip modification, double-guide wire assistance, 5in6 support, the use of spherical tip non compliant balloon(APT Medical Inc，CONQUEROR NC Pro) and so on.

Group Type: ACTIVE_COMPARATOR

Regular noncompliant balloon

Intervention Type: DEVICE

The balloon is designed as tapered-tip.

Interventions

Spherical tip noncompliant balloon

The main difference of this experimental balloon is the spherical tip, other parameters are consistent with regular noncompliant balloons.

Intervention Type: DEVICE

Regular noncompliant balloon

The balloon is designed as tapered-tip.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The People's Hospital of Liaoning Province

OTHER

Sponsor Role: collaborator

First Hospital of China Medical University

OTHER

Sponsor Role: lead

Responsible Party

Yingxian Sun

Chief of Department of Cardiology in First Hospital of China Medical University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yingxian Sun, Phd

Role: PRINCIPAL_INVESTIGATOR

First Hospital of China Medical University

Locations

First Hospital of China Medical University

Shenyang, Liaoning, China

Countries

China

Other Identifiers

[2023]25

Identifier Type: -

Identifier Source: org_study_id