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

Sponsor
First Hospital of China Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05856344
Collaborator
The People's Hospital of Liaoning Province (Other)
236
1
2
8.8
26.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Spherical tip noncompliant balloon
  • Device: Regular noncompliant balloon
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
236 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Feb 20, 2023
Anticipated Primary Completion Date :
Nov 15, 2023
Anticipated Study Completion Date :
Nov 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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

Active Comparator: 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.

Device: Regular noncompliant balloon
The balloon is designed as tapered-tip.

Outcome Measures

Primary Outcome Measures

  1. Success passage rate at the first attempt [From start to end of surgery]

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

Secondary Outcome Measures

  1. The final success passage rate [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 [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 [From start to end of surgery]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 First Hospital of China Medical University Shenyang Liaoning China 110001

Sponsors and Collaborators

  • First Hospital of China Medical University
  • The People's Hospital of Liaoning Province

Investigators

  • Principal Investigator: Yingxian Sun, Phd, First Hospital of China Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yingxian Sun, Chief of Department of Cardiology in First Hospital of China Medical University, First Hospital of China Medical University
ClinicalTrials.gov Identifier:
NCT05856344
Other Study ID Numbers:
  • [2023]25
First Posted:
May 12, 2023
Last Update Posted:
May 12, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yingxian Sun, Chief of Department of Cardiology in First Hospital of China Medical University, First Hospital of China Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 12, 2023