Angioplasty, Coronary Artery Disease
Conditions
Keywords
coronary heart disease, large coronary vessel, optical coherence tomography, Drug-coated Balloon, Drug-eluting Stent
Brief summary
OCT allows precise evaluation of intimal injury after lesion preparation and may improve the acute results and long-term outcomes after paclitaxel drug-coated balloon angioplasty. This prospective multicenter randomized controlled study aims to evaluate the long-term efficacy and safety of paclitaxel coated balloon in the treatment of native large coronary arteries by OCT guided is not inferior to drug-eluting stent.
Interventions
DEVICEDCB for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography
DCB for de Novo Lesions in Large Coronary Arteries Guided by both angiogram and Optical Coherence Tomography
Sponsors
Liu Bin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
18 to 75 years old Patients have ischemic symptoms or evidence of myocardial ischemia (inducible or spontaneous) in the presence of a stenosis of at least 50% in a native coronary artery, including stable angina, unstable angina, silent ischemia or myocardial infarction（≥1month） . Reference vessel diameter ≥3.0 mm, and \<4.5mm. Lesion length of ≤20 mm Written informed consent
Exclusion criteria
Myocardial infarction within 4 weeks, including ST-elevation myocardial infarction and non-ST-elevation myocardial infarction Cardiogenic shock (systolic arterial pressure \<90mmHg), congestive heart failure (NYHA=4，EF≤35%) Severe valvular heart disease Life expectancy no more than 1 year or factors causing difficulties in clinical follow up Intolerance to aspirin and/or clopidogrel, ticagrelor Known intolerance or allergy to heparin, contrast agents, paclitaxel, iopromide, rapamycin, polylactic acid-glycolic acid copolymer, Co-Cr alloy or platinum-chromium alloy Leukopenia or thrombopenia A history of peptic ulcer or GI bleeding in the previously Stroke within 6 months prior to the operation A history of severe hepatic or renal failure Stents covering a major side branch (≥2.5 mm need to intervention) Left main lesion Graft lesion Aortic-coronary ostial lesion In-stent restenotic lesion Chronic total occlusion Severe calcified lesions. Visible angiographic thrombus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| late lumen loss （LLL） | Follow-up coronary angiography at 12 months after the procedure | late lumen loss between DCB treated group and DES treated group evaluated by quantitative coronary analysis in patients with CHD |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence rate of device-related ischemic events | Clinical follow up at 30 days, 3，6, 9 and 12 months after the procedure | The incidence rate of device-related ischemic events including cardiovascular death, target vessel related myocardial infarction and ischemia-driven revascularization between DCB treated group and DES treated group |
| The incidence rate of patient-related ischemic events | Clinical follow up at 30 days, 3，6, 9 and 12 months after the procedure | TThe incidence rate of patient-related ischemic events including all myocardial infarction , any revascularization and all-cause death between DCB treated group and DES treated group |
Countries
China
Outcome results
None listed