Coronary Artery Disease, Drug-coated Balloon
Conditions
Brief summary
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).
Detailed description
Patients were randomly assigned (1:1) to receive angioplasty with DCB or implantation of a DES. Dual anti-platelet therapy was given according to current guidelines. Follow-up was originally scheduled at by telephone or clinical visit at 1 month, 6 months, and 12 months after discharge. The primary endpoint is a composite endpoint of cardiac death, target vessel related myocardial infarction, and target lesion revascularization (TLF) at 12 months follow up.
Interventions
DEVICEDrug-Coated Balloon
Drug-coated balloon is a fast-exchange balloon dilatation catheter, used to treat coronary artery stenosis lesions.
DEVICESirolimus-Eluting Stent
Sirolimus-Eluting Stent is treated for coronary artery stenosis lesions.
Sponsors
Lepu Medical Technology (Beijing) 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
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 (\<100×10⁹/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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target lesion failure | 12 months follow-up | A composite endpoint consisting of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural success | During the hospital stay, up to 7 days after PCI | 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). |
| Target lesion failure | 1 month, 6months follow-up | A composite endpoint consisting of cardiac death, target vessel-related myocardial infarction, and target lesion revascularization |
| Patient-oriented composite endpoint | 1 month, 6months,12 months follow-up | A composite of all-cause mortality, myocardial infarction, and any revascularization |
Contacts
Primary ContactYansong Li
Outcome results
None listed