Coronary Artery Disease Clinical Trial
Official title:
A Prospective, Multi-center, Randomized Trial Comparing the Long-term Efficacy of Drug-coated Balloon Versus Drug-eluting Stent in Large de Novo Coronary Lesions
To evaluate the efficacy of drug-coated balloon versus drug-eluting stent for the treatment of large de novo coronary lesions(RVD=2.75~4.0mm).
Status | Not yet recruiting |
Enrollment | 400 |
Est. completion date | November 2023 |
Est. primary completion date | November 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Age =18 years and =80 years, regardless of gender; 2. De novo lesion in a native coronary artery; 3. Stable angina, or unstable angina, or old myocardial infarction or asymptomatic myocardial ischemia; 4. Reference vessel diameter is 2.75mm-4.0mm with diameter stenosis =70% or =50% (with evidence of ischemia) and TIMI flow =1; 5. The subject can receive any type of coronary vascular revascularization (including balloon angioplasty, stent implantation or coronary artery bypass grafting); 6. The subject who can understand the purpose of the trial, voluntarily participate in and sign an informed consent form, and is willing to accept clinical follow-up. Exclusion Criteria: 1. Reference vessel diameter <2.75 mm or >4.0 mm; 2. In stent restenosis; 3. Left main lesion, chronic complete occlusion lesion; 4. Ostial lesion =2mm from the LM, or bifurcation lesion with branch vessel diameter=2.5mm; 5. There is a large scale of thrombus in the target vessel, and the thrombus grade >3 after thrombolysis or aspiration; 6. Severe heart failure (NYHA IV); 7. Severe renal failure (GFR<30ml/min) or undergoing hemodialysis treatment; 8. Severe liver failure (bilirubin is over 2 times the upper limit of normal, or alanine aminotransferase is over 3 times the upper limit of normal); 9. Patients with vein graft restenosis after bypass or severe heart valve disease; 10. Pregnant or breastfeeding female patients; 11. The life expectancy of the patient is less than 12 months; 12. The subject cannot be treated with anticoagulation because of bleeding tendency, history of active peptic ulcer, stroke in the 6 months before surgery, anti-platelet agents or anticoagulant treatment contraindications; 13. Anemia (women's hemoglobin <117g/L, or men's hemoglobin <134g/L), or thrombocytopenia detected before the intervention within 6 months (<100×10?/L); 14. Planned to perform non-cardiac surgery within 12 months after index procedure; 15. The subject who participated in other clinical trials of drugs or instruments and did not reach time of primary endpoint; 16. Heart transplant patients; 17. Allergic to aspirin, clopidogrel, heparin, contrast agents, or paclitaxel; 18. The investigator judged that the patient had poor compliance and could not complete the study as required. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
---|---|
Lepu Medical Technology (Beijing) Co., Ltd. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Target lesion failure | A composite endpoint consisting of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization | 12 months follow-up | |
Secondary | Procedural success | Consisting of device success ( after successful delivery of the study balloon, the visual residual stenosis of the target lesion is less than 50%, TIMI level 3 blood flow ) , Lesion success (defined as the proportion of the target lesions in which the final stenosis is <20% after treatment with any other adjunctive therapy ) , Clinical success ( Defined as no major adverse cardiac events caused by ischemia during the subject's hospitalization). | During the hospital stay, up to 7 days after PCI | |
Secondary | Target lesion failure | A composite endpoint consisting of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization | 1 month, 6months follow-up | |
Secondary | Patient-oriented composite endpoint | A composite of all-cause mortality, myocardial infarction, and any revascularization | 1 month, 6months,12 months follow-up |
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