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Completed

NCT Number: NCT05856344

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spherical tip noncompliant balloon

Device

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

Regular noncompliant balloon

Device

The balloon is designed as tapered-tip.

Primary outcomes

  1. Success passage rate at the first attempt

    Time frame: From start to end of surgery

    The success passage rate of the noncompliant balloon through the tortuous target lesion at the first attempt

Secondary outcomes

  1. The final success passage rate

    Time frame: From start to end of surgery

    The final success passage rate of the noncompliant balloon through the tortuous target lesion under three attempts

  2. The number of attempts

    Time frame: From start to end of surgery

    The number of attempts required for the noncompliant balloon to pass through the tortuous target lesion

  3. The time required

    Time frame: From start to end of surgery

    The time required for the noncompliant balloon to pass through the tortuous target lesion

  4. Major adverse cardiac event

    Time frame: 3 months after percutaneous coronary intervention

    defined as death from all, cardiac, or noncardiac causes, myocardial infarction, repeat revascularization and stroke during follow-up

Sponsors and collaborators

Lead sponsor

First Hospital of China Medical University

Other

Collaborators

  • The People's Hospital of Liaoning Province

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 12, 2023
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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