A Study for Crossability of Spherical Tip Versus Regular Noncompliant Balloon in Tortuous Coronary Artery Postdilatation
Coronary Artery Disease
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
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
Experimental
Active Comparator
Spherical tip noncompliant balloon
Regular 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.
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.