MedTrace Logo

A Randomized Study of Cutting Balloon Catheter for CAD

NCT07140822 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2025-08-26

No results posted yet for this study

Summary

This study is designed as a prospective, multi-center, non-inferiority and randomized controlled clinical trial. A total of 158 eligible subjects from 18 sites across the country is planned to be enrolled, and they will be randomly assigned to the test group and the control group according to a ratio of 1:1 for balloon dilatation for the treatment of coronary artery disease.

Conditions

Interventions

DEVICE

Coronary Cutting Balloon Catheter

This product uses a pressure device to pressurize the balloon to expand it. The blades designed on the surface of the balloon produce a cutting effect on the vascular lesions, allowing it to better embed into the plaque.

DEVICE

VesscideTM Cutting Balloon System

This product utilizes a pressure mechanism to inflate the balloon, causing it to expand. The blades on the balloon's surface create a cutting action on the vascular lesions, enabling the device to penetrate the plaque more effectively.

Sponsors & Collaborators

  • Shanghai Shenqi Medical Technology Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-26
Primary Completion
2023-07-24
Completion
2023-10-10

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07140822 on ClinicalTrials.gov