MedTrace Logo

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

NCT05856344 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2025-01-14

No results posted yet for this 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.

Conditions

Interventions

DEVICE

Spherical tip noncompliant balloon

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

DEVICE

Regular noncompliant balloon

The balloon is designed as tapered-tip.

Sponsors & Collaborators

  • The People's Hospital of Liaoning Province

    collaborator OTHER

  • First Hospital of China Medical University

    lead OTHER

Principal Investigators

  • Yingxian Sun, Phd · First Hospital of China Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-20
Primary Completion
2024-08-27
Completion
2024-12-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05856344 on ClinicalTrials.gov