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

China Medical University

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: Spherical tip noncompliant balloon; Device: Regular noncompliant balloon

Study type: Interventional

Funder types: Other

Identifiers

NCT05856344

[2023]25

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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250 participants in 2 patient groups

Spherical tip noncompliant balloon

Experimental group

Description:

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.

Treatment:

Device: Spherical tip noncompliant balloon

Regular noncompliant balloon

Active Comparator group

Description:

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.

Treatment:

Device: Regular noncompliant balloon