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

Last updated: January 10, 2025
Sponsor: First Hospital of China Medical University
Overall Status: Completed

Phase

N/A

Condition

Chest Pain

Coronary Artery Disease

Hypercholesterolemia

Treatment

Regular noncompliant balloon

Spherical tip noncompliant balloon

Clinical Study ID

NCT05856344
[2023]25
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 250
Treatment Group(s): 2
Primary Treatment: Regular noncompliant balloon
Phase:
Study Start date:
February 20, 2023
Estimated Completion Date:
December 01, 2024

Study 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.

Connect with a study center

  • First Hospital of China Medical University

    Shenyang, Liaoning 110001
    China

    Site Not Available

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