Clinical Trial on Safety and Efficacy of Drug-coated Balloon in Treatment of Coronary Bifurcation Lesions

Study Overview
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Brief Summary
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The objective of this study is to evaluate the safety and efficacy of paclitaxel-coated balloon in treatment of coronary bifurcation lesions. This is a feasible study to demonstrate the noninferiority of paclitaxel Drug-coated balloon(DCB) only strategy for bifurcation lesions when compared with traditional single drug eluting stent(DES) strategy, so as to simplify the procedure for treatment of coronary bifurcation lesions and extending the clinical indications of paclitaxel DCB in China.

Detailed Description
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Paclitaxel DCB is designed to release anti-proliferative agents to the whole lesion rapidly and homogenously to inhibit excessive neointima proliferation and is associated with rapid healing of endothelium. As a result, DCB therapy reduces the risk of coronary thrombosis. Since only 1 to 3 months duration of dual anti-platelet therapy is required, the bleeding risk associated with prolonged dual anti-platelet therapy (DAPT) is reduced by DCB. Furthermore, there is no permanent residue of foreign bodies in the blood vessels after DCB procedure and this advantage completely eliminates adverse events associated with allergic reactions to metal, polymer and stent fracture. For side branch(SB) with a relatively small lumen in bifurcation lesions, DCB may neglect the lumen loss due to stent scaffolds and cause much less late lumen loss (LLL) than stent therapy does. For main branch(MB), no jailed SBs by the stent and the rate of SB stenosis or even occlusion will be greatly reduced.

Official Title
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Clinical Trial on Safety and Efficacy of Drug-coated Balloon in Treatment of Coronary Bifurcation Lesions

Conditions
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Coronary Disease

Intervention / Treatment
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* Device: Paclitaxel DCB
* Device: DES


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient-related criteria： Patients with stable angina, unstable angina, old myocardial infarction or evidence of asymptomatic myocardial ischemia and consent to receive coronary intervention therapy; Aged between 18 and 80 years; Consent to receive angiographic follow up at 9 months and clinical follow up at 30 days, 6, 9, 12 and 24 months. Lesion-related criteria： Target lesions of Medina (0,1,1), (1,0,1) or (1,1,1) primary coronary bifurcation lesions without previous intervention therapy; MB reference vessel diameter between 2.5 mm and 3.5 mm and length ≤30mm; SB reference vessel diameter between 2.0 mm and 3.0 mm and length ≤22 mm; Pre-operative vessel diameter stenosis must ≥70% or ≥50% associated with local ischemia; After lesion predilation, no dissection is seen, or type A/B dissection can be seen, residual stenosis ≤30% and TIMI(thrombolysis in myocardial infarction) grade 3 flow; The distance between other lesions requiring intervention therapy and the target lesion must >10mm ; Only one drug-eluting balloon or drug-eluting stent is used in treatment of MB and SB lesions. Exclusion Criteria: Patient-related criteria： Myocardial infarction in the previous week; Severe congestive heart failure[LVEF <30% or NYHA( New York Heart Association) III/IV)] Severe valvular heart disease; Pregnant or breastfeeding women; Life expectancy no more than 1 year or factors causing difficulties in clinical follow up; Bleeding predisposition, contraindications of anticoagulants or antiplatelet agents; Intolerance to aspirin and/or clopidogrel; 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. Lesion-related criteria ： Extensive thrombosis in the target vessel; Percutaneous coronary intervention of the graft vessel; Chronic total occlusions (pre-operative TIMI grade 0 flow); Left main branch lesions and /or three-vessel lesions requiring treatment; Lesions that are not indications of PTCA(percutaneous transluminal coronary angiography) or other intervention therapy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Paclitaxel DCB for MB and/or SB<br>Balloon/vessel diameter ratio 0.8-1.0, 8-10 ATM(atmosphere), lasting for >30 seconds | Device: Paclitaxel DCB<br>* Balloon/vessel diameter ratio 0.8-1.0, 8-10 ATM, lasting for >30 seconds. If quantitative coronary angiography determines residual stenosis ≤ 30% , it is considered to be a successful operation.<br>|
| Active Comparator: DES in MB<br>with regular techniques | Device: DES<br>* MB should be sufficiently predilated to facilitate the positioning of the stent and the stent residual stenosis should be ≤10% to be a successful operation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QCA(quantitative coronary analysis) of efficacy of DCB | late lumen loss, minimal lumen diameter | Follow-up coronary angiography at 9 months after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| device-related ischemic events | including cardiovascular death, target vessel related myocardial infarction and ischemia-driven revascularization | Clinical follow up at 30 days, 6, 9, 12 and 24 months after the procedure | 
| patient-related ischemic events | all myocardial infarction , any revascularization and all-cause death | Clinical follow up at 30 days, 6, 9, 12 and 24 months after the operation | 
| ARC（Academic Research Consortium） defined target vessel thrombus events | definite, probable and possible target vessel thrombus | Clinical follow up at 30 days, 6, 9, 12 and 24 months after the operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug-coated balloon, Angioplasty, bifurcation