Drug-coated Balloon Versus Drug-eluting Stent for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography
- Conditions
- Coronary Artery DiseaseAngioplasty
- Interventions
- Device: DCB for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography
- Registration Number
- NCT04664283
- Lead Sponsor
- Liu Bin
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 254
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DES group by OCT guided DCB for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography - DCB group by OCT guided DCB for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (2)
the Second hospital of Jilin University
🇨🇳Chang chun, Ji Lin, China
The Second Hospital of Jilin University
🇨🇳Changchun, Jilin, China