Coronary Artery DiseaseNCT05856344
A Study for Crossability of Spherical Tip Versus Regular Noncompliant Balloon in Tortuous Coronary Artery Postdilatation
A study testing Spherical tip noncompliant balloon and Regular noncompliant balloon in people with Coronary Artery Disease, run by First Hospital of China Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Spherical tip noncompliant balloon and Regular noncompliant balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2023to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
First Hospital of China Medical University
Shenyang, Liaoning, 110001
About this study
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
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Spherical tip noncompliant balloon, Regular noncompliant balloon
- Keywords
- Coronary Artery Disease, Spherical Tip, Noncompliant Balloon, Postdilation, Percutaneous Coronary Intervention
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spherical tip noncompliant balloonDevice
The main difference of this experimental balloon is the spherical tip, other parameters are consistent with regular noncompliant balloons.
Regular noncompliant balloonDevice
The balloon is designed as tapered-tip.
| Study group | Role | What they receive |
|---|---|---|
| Spherical tip noncompliant balloon | Experimental | 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. Receives: Device: Spherical tip noncompliant balloon |
| Regular noncompliant balloon | Active comparator | 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. Receives: Device: Regular noncompliant balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success passage rate at the first attempt
The success passage rate of the noncompliant balloon through the tortuous target lesion at the first attempt
Measured: From start to end of surgery
Secondary outcomes (4)
The final success passage rate
The final success passage rate of the noncompliant balloon through the tortuous target lesion under three attempts
Measured: From start to end of surgery
The number of attempts
The number of attempts required for the noncompliant balloon to pass through the tortuous target lesion
Measured: From start to end of surgery
The time required
The time required for the noncompliant balloon to pass through the tortuous target lesion
Measured: From start to end of surgery
Major adverse cardiac event
defined as death from all, cardiac, or noncardiac causes, myocardial infarction, repeat revascularization and stroke during follow-up
Measured: 3 months after percutaneous coronary intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start20 Feb 2023
- Primary completion27 Aug 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Hospital of China Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- The People's Hospital of Liaoning Province
- Responsible party
- Principal investigator, Yingxian Sun, First Hospital of China Medical University
- Investigators
- Yingxian Sun, Phd, Principal investigator, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05856344
- Sponsor's protocol ID
- [2023]25
- Status last verified
- Jan 2025
- First submitted
- 4 May 2023
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05856344
- Acronym / sponsor ID
- [2023]25
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, Spherical Tip, Noncompliant Balloon, Postdilation, Percutaneous Coronary Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- First Hospital of China Medical UniversityUniversity, hospital or other
- Collaborators
- The People's Hospital of Liaoning Province
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 27 Aug 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 12 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spherical tip noncompliant balloon | Experimental | Device: Spherical tip noncompliant balloonEnrolled 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. |
| Regular noncompliant balloon | Active comparator | Device: Regular noncompliant balloonEnrolled 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spherical tip noncompliant balloonThe main difference of this experimental balloon is the spherical tip, other parameters are consistent with regular noncompliant balloons. | Device | Spherical tip noncompliant balloon |
| Regular noncompliant balloonThe balloon is designed as tapered-tip. | Device | Regular noncompliant balloon |
Primary outcome
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
4 secondary outcomes
The final success passage rate
Time frame: From start to end of surgery
The number of attempts
Time frame: From start to end of surgery
The time required
Time frame: From start to end of surgery
Major adverse cardiac event
Time frame: 3 months after percutaneous coronary intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yingxian Sun, Phd principal investigator
First Hospital of China Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spherical tip noncompliant balloon and Regular noncompliant balloon in people with Coronary Artery Disease, run by First Hospital of China Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success passage rate at the first attempt (time frame: From start to end of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.