Drug-coated Balloon Versus Drug-eluting Stent for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography

Study Overview
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Brief Summary
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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.

Official Title
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Drug-coated Balloon Versus Drug-eluting Stent for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography：a Prospective Multi-center Randomized Controlled Trial

Conditions
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Angioplasty, Coronary Artery Disease

Intervention / Treatment
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* Device: DCB for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DCB group by OCT guided<br> | Device: DCB for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography<br>* DCB for de Novo Lesions in Large Coronary Arteries Guided by both angiogram and Optical Coherence Tomography<br>* Other names: DES for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography;|
| Active Comparator: DES group by OCT guided<br> | Device: DCB for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography<br>* DCB for de Novo Lesions in Large Coronary Arteries Guided by both angiogram and Optical Coherence Tomography<br>* Other names: DES for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| late lumen loss （LLL） | late lumen loss between DCB treated group and DES treated group evaluated by quantitative coronary analysis in patients with CHD | Follow-up coronary angiography at 12 months after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence rate of device-related ischemic events | 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 | Clinical follow up at 30 days, 3，6, 9 and 12 months after the procedure | 
| The incidence rate of patient-related ischemic events | 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 | Clinical follow up at 30 days, 3，6, 9 and 12 months after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary heart disease, large coronary vessel, optical coherence tomography, Drug-coated Balloon, Drug-eluting Stent