Clinical trial NCT05856344: A Study for Crossability of Spherical Tip Versus Regular Noncompliant Balloon in Tortuous Coronary Artery Postdilatation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease
Spherical Tip
Noncompliant Balloon
Postdilation
Percutaneous Coronary Intervention
Lead sponsor: First Hospital of China Medical University
Sponsor class: OTHER
Collaborators: name: The People's Hospital of Liaoning Province
First posted: 2023-05-12
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Success passage rate at the first attempt
timeFrame: From start to end of surgery
Secondary outcomes:
measure: The final success passage rate
timeFrame: From start to end of surgery
measure: The number of attempts
timeFrame: From start to end of surgery
measure: The time required
timeFrame: From start to end of surgery
measure: Major adverse cardiac event
timeFrame: 3 months after percutaneous coronary intervention
Other outcomes:
Locations:
city: Shenyang
country: China
facility: First Hospital of China Medical University
state: Liaoning
Study officials:
affiliation: First Hospital of China Medical University
name: Yingxian Sun, Phd
role: PRINCIPAL_INVESTIGATOR
References: