search
Back to results

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

Primary Purpose

Coronary Artery Disease

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Spherical tip noncompliant balloon
Regular noncompliant balloon
Sponsored by
First Hospital of China Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, Spherical Tip, Noncompliant Balloon, Postdilation, Percutaneous Coronary Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • First Hospital of China Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Spherical tip noncompliant balloon

Regular noncompliant balloon

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The final success passage rate
The final success passage rate of the noncompliant balloon through the tortuous target lesion under three attempts
The number of attempts
The number of attempts required for the noncompliant balloon to pass through the tortuous target lesion
The time required
The time required for the noncompliant balloon to pass through the tortuous target lesion

Full Information

First Posted
May 4, 2023
Last Updated
May 4, 2023
Sponsor
First Hospital of China Medical University
Collaborators
The People's Hospital of Liaoning Province
search

1. Study Identification

Unique Protocol Identification Number
NCT05856344
Brief Title
A Study for Crossability of Spherical Tip Versus Regular Noncompliant Balloon in Tortuous Coronary Artery Postdilatation
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2023 (Actual)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
November 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Hospital of China Medical University
Collaborators
The People's Hospital of Liaoning Province

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary Artery Disease, Spherical Tip, Noncompliant Balloon, Postdilation, Percutaneous Coronary Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
236 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Spherical tip noncompliant balloon
Arm Type
Experimental
Arm 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.
Arm Title
Regular noncompliant balloon
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Spherical tip noncompliant balloon
Intervention Description
The main difference of this experimental balloon is the spherical tip, other parameters are consistent with regular noncompliant balloons.
Intervention Type
Device
Intervention Name(s)
Regular noncompliant balloon
Intervention Description
The balloon is designed as tapered-tip.
Primary Outcome Measure Information:
Title
Success passage rate at the first attempt
Description
The success passage rate of the noncompliant balloon through the tortuous target lesion at the first attempt
Time Frame
From start to end of surgery
Secondary Outcome Measure Information:
Title
The final success passage rate
Description
The final success passage rate of the noncompliant balloon through the tortuous target lesion under three attempts
Time Frame
From start to end of surgery
Title
The number of attempts
Description
The number of attempts required for the noncompliant balloon to pass through the tortuous target lesion
Time Frame
From start to end of surgery
Title
The time required
Description
The time required for the noncompliant balloon to pass through the tortuous target lesion
Time Frame
From start to end of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guozhe Sun, Phd
Phone
15040292137
Email
gzhsun66@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zihan Chen, Phd
Phone
18309869697
Email
449161707@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yingxian Sun, Phd
Organizational Affiliation
First Hospital of China Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guozhe Sun, Phd
Phone
15040292137
Email
gzhsun66@163.com
First Name & Middle Initial & Last Name & Degree
Zihan Chen, Phd
Phone
18309869697
Email
449161707@qq.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs