Status:
COMPLETED
A Randomized Study of Cutting Balloon Catheter for CAD
Lead Sponsor:
Shanghai Shenqi Medical Technology Co., Ltd
Conditions:
Coronary Artery Disease
Percutaneous Coronary Intervention (PCI)
Eligibility:
All Genders
18-80 years
Phase:
NA
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 enro...
Eligibility Criteria
Inclusion
- 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:
- 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;
- 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;
- Clinicians expect that the risk of interventional surgery is extremely high or other cases that should be ruled out;
- 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 exclusion criteria:
- Left main lesion or lesion at a distance of ≤ 2 mm from the left main coronary artery;
- Patients with thrombosis suggested by angiography;
- Patients with a total occluded lesion and a TIMI flow grade 0;
- Coronary artery spasm (CAS) without organic stenosis;
- Left main lesion without protection from bypass grafts or collateral flow;
- In addition to the above contraindications, conditions diagnosed by the physician as unsuitable for the use of the device.
Exclusion
Key Trial Info
Start Date :
April 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2023
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT07140822
Start Date
April 26 2023
End Date
October 10 2023
Last Update
August 26 2025
Active Locations (1)
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1
Meizhou People's Hospital
Meizhou, Guangdong, China, 514031