Coronary Artery Disease
Conditions
Keywords
Coronary Artery Disease, Spherical Tip, Noncompliant Balloon, Postdilation, Percutaneous Coronary Intervention
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.
Interventions
DEVICESpherical tip noncompliant balloon
The main difference of this experimental balloon is the spherical tip, other parameters are consistent with regular noncompliant balloons.
DEVICERegular noncompliant balloon
The balloon is designed as tapered-tip.
Sponsors
The People's Hospital of Liaoning Province
First Hospital of China Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success passage rate at the first attempt | From start to end of surgery | The success passage rate of the noncompliant balloon through the tortuous target lesion at the first attempt |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The final success passage rate | From start to end of surgery | The final success passage rate of the noncompliant balloon through the tortuous target lesion under three attempts |
| The number of attempts | From start to end of surgery | The number of attempts required for the noncompliant balloon to pass through the tortuous target lesion |
| The time required | From start to end of surgery | The time required for the noncompliant balloon to pass through the tortuous target lesion |
| Major adverse cardiac event | 3 months after percutaneous coronary intervention | defined as death from all, cardiac, or noncardiac causes, myocardial infarction, repeat revascularization and stroke during follow-up |
Countries
China
Outcome results
None listed