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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05856344
Other study ID # [2023]25
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 20, 2023
Est. completion date November 15, 2023

Study information

Verified date May 2023
Source First Hospital of China Medical University
Contact Guozhe Sun, Phd
Phone 15040292137
Email gzhsun66@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 236
Est. completion date November 15, 2023
Est. primary completion date November 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Device:
Spherical tip noncompliant balloon
The main difference of this experimental balloon is the spherical tip, other parameters are consistent with regular noncompliant balloons.
Regular noncompliant balloon
The balloon is designed as tapered-tip.

Locations

Country Name City State
China First Hospital of China Medical University Shenyang Liaoning

Sponsors (2)

Lead Sponsor Collaborator
First Hospital of China Medical University The People's Hospital of Liaoning Province

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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
Secondary The number of attempts The number of attempts required for the noncompliant balloon to pass through the tortuous target lesion From start to end of surgery
Secondary The time required The time required for the noncompliant balloon to pass through the tortuous target lesion From start to end of surgery
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