Calcified Coronary Lesions, Coronary Artery Disease, Percutaneous Coronary Intervention (PCI)
Conditions
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.
Interventions
DEVICECoronary 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.
DEVICEVesscideTM 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
Shanghai Shenqi Medical Technology Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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. General
Exclusion criteria
1. Pregnant or lactating women or women who are planning pregnancy; 2. 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; 3. 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; 4. 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; 5. NYHA Class IV patients; 6. Patients with severe renal failure (creatinine \> 443 μmol/L) or ongoing hemodialysis therapy; 7. Heart transplant patients; 8. Patients with graft vessel disease; 9. Patients with hemodynamic instability or symptoms of shock; 10. Patients with a life expectancy of no more than 1 year; 11. Patients who are expected to undergo elective surgery within 1 month; 12. Patients not eligible for coronary artery bypass grafting (CABG) procedure; 13. 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; 14. Patients who are known to be allergic or contraindicated to heparin, contrast agents, etc.; 15. Patients who are suffering from diseases that can cause difficulties in treatment and evaluation; 16. Patients who have been selected and have participated in trials with other drug or medical device but have not reached the time limit of the primary study endpoint; 17. Clinicians expect that the risk of interventional surgery is extremely high or other cases that should be ruled out; 18. Patients who, in the judgment of the investigator, are poor compliance with the therapy and are unable to complete the trial as required; Lesion related
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute gain | Before and after balloon dilation | 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. |
Countries
China
Outcome results
None listed