- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05856344
A Study for Crossability of Spherical Tip Versus Regular Noncompliant Balloon in Tortuous Coronary Artery Postdilatation
A Study for Crossability of Novel Spherical Tip Versus Regular Noncompliant Balloon in Tortuous Coronary Artery Postdilatation:A Multicenter, Randomized, Controlled, Single Blind Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Guozhe Sun, Phd
- Phone Number: 15040292137
- Email: gzhsun66@163.com
Study Contact Backup
- Name: Zihan Chen, Phd
- Phone Number: 18309869697
- Email: 449161707@qq.com
Study Locations
-
-
Liaoning
-
Shenyang, Liaoning, China, 110001
- Recruiting
- First Hospital of China Medical University
-
Contact:
- Guozhe Sun, Phd
- Phone Number: 15040292137
- Email: gzhsun66@163.com
-
Contact:
- Zihan Chen, Phd
- Phone Number: 18309869697
- Email: 449161707@qq.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
The balloon is designed as tapered-tip.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
From start to end of surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
From start to end of surgery
|
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
|
From start to end of surgery
|
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
|
From start to end of surgery
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Yingxian Sun, Phd, First Hospital of China Medical University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- [2023]25
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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