A Randomized Study of Cutting Balloon Catheter for CAD

NCT07140822 | Completed DMC

• 1 other identifier: CCBP01
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief 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

Coronary Artery Disease; Percutaneous Coronary Intervention (PCI); Calcified Coronary Lesions

Outcome Measures

Primary Outcomes (1)

• Acute gain

  The acute gain is defined as the difference in minimal lumen diameter (MLD) of the target lesions measured by quantitative coronary angiography (QCA) before and after the balloon dilatation using balloons from the test group/control group.

  Before and after balloon dilation

Study Arms (2)

Coronary Cutting Balloon Catheter

EXPERIMENTAL

Device: Coronary Cutting Balloon Catheter

VesscideTM Cutting Balloon System

ACTIVE COMPARATOR

Device: VesscideTM Cutting Balloon System

Interventions

Coronary Cutting Balloon Catheter DEVICE

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.

Coronary Cutting Balloon Catheter

VesscideTM Cutting Balloon System DEVICE

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.

VesscideTM Cutting Balloon System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged 18-80 years, including 18 and 80 years;
• Patients with stable or unstable angina, or old myocardial infarction or clinically judged silent myocardial ischemia (target vessel reference vessel diameter 2.00-4.00 mm (both inclusive)), luminal diameter stenosis ≥ 70%, or ≥ 50% by visual inspection with evidence of ischemia, TIMI blood flow ≥ grade 1, and requiring treatment with a cutting balloon dilatation catheter as considered by the operator;
• Able to understand the purpose of the study, participate the study willingly, sign the written informed consent form, and are available for and willing to follow-up as defined in this trial.

You may not qualify if:

• Pregnant or lactating women or women who are planning pregnancy;
• Subjects with myocardial infarction occurred within one week; the myocardial enzyme TNI or TNT has not returned to normal although myocardial infarction has occurred for more than one week;
• Subjects who are considered by the investigator through angiography that the cutting balloon cannot pass through even dilatation with a small one and need a rotational atherectomy;
• Non-target vessels, which can be treated simultaneously with the target blood vessel, have not been treated well in advance, or the total number of lesions on the non-target blood vessel is \> 3;
• NYHA Class IV patients;
• Patients with severe renal failure (creatinine \> 443 μmol/L) or ongoing hemodialysis therapy;
• Heart transplant patients;
• Patients with graft vessel disease;
• Patients with hemodynamic instability or symptoms of shock;
• Patients with a life expectancy of no more than 1 year;
• Patients who are expected to undergo elective surgery within 1 month;
• Patients not eligible for coronary artery bypass grafting (CABG) procedure;
• Patients with a predisposition to bleeding, a history of active peptic ulcer, or contraindications to antiplatelet agents and anticoagulants, patients who cannot undergo anticoagulant therapy, or patients who have experienced hemorrhagic stroke within 6 months;
• Patients who are known to be allergic or contraindicated to heparin, contrast agents, etc.;
• Patients who are suffering from diseases that can cause difficulties in treatment and evaluation;

Sponsors & Collaborators

• Shanghai Shenqi Medical Technology Co., Ltd: lead

Study Sites (1)

Meizhou People's Hospital

Meizhou, Guangdong, 514031, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: August 26, 2025
• Study Start: April 26, 2023
• Primary Completion: July 24, 2023
• Study Completion: October 10, 2023
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)