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| Name | Class |
|---|---|
| The People's Hospital of Liaoning Province | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spherical tip noncompliant balloon | Device | The main difference of this experimental balloon is the spherical tip, other parameters are consistent with regular noncompliant balloons. |
| Measure | Description | Time Frame |
|---|---|---|
| Success passage rate at the first attempt | The success passage rate of the noncompliant balloon through the tortuous target lesion at the first attempt | From start to end of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| The final success passage rate | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yingxian Sun, Phd | First Hospital of China Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Hospital of China Medical University | Shenyang | Liaoning | 110001 | China |
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| Regular noncompliant balloon | Device | The balloon is designed as tapered-tip. |
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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 | The time required for the noncompliant balloon to pass through the tortuous target lesion | 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 | 3 months after percutaneous coronary intervention |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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