Yao Strategy for the Treatment of de Novo Medina 0,1,0 or 0,0,1 Bifurcation Lesion

Study Overview
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Brief Summary
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Percutaneous coronary intervention for coronary bifurcation lesions represents one of the most challenging procedures in interventional cardiology because of lower angiographic success rate and increased risk of procedural complications. The study is designed to enroll 200 patients with acute or chronic coronary syndromes that meet the indications for intervention and with angiographic confirmed de novo Medina type 0,1,0 or 0,0,1 bifurcation lesion. In view of the potential risks of using DCB alone in the treatment of de novo bifurcation lesions, the following 2 treatment strategies are available. (1) DCB combined with provisional DES implantation 1-2 mm distally to the lesion ostium whenever this was required (DCB+pDES strategy). (2) DES implantation 1-2 mm distally to the lesion ostium followed by DCB (DES+DCB strategy). The primary endpoint was late lumen loss and major adverse cardiovascular events.

Official Title
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Drug-coated Balloon Combined With Provisional Drug-eluting Stent Implantation (Yao Strategy) for the Treatment of de Novo Medina 0,1,0 or 0,0,1 Bifurcation Lesion

Conditions
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Coronary Artery Disease, Bifurcation Lesion

Intervention / Treatment
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* Procedure: Drug-coated balloon combined with provisional drug-eluting stent implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects at the age between ≥18 and ≤80 years old; De novo native lesion, Median type 010/001 bifurcation lesion; The reference diameter of the target vessel was 2.75-4.0mm and the length was less than 40mm; Subjects are willing to participate in the study, sign informed consent form, and accept clinical follow-up. Exclusion Criteria: The diameter stenosis of adjacent branch vessel ostium ≥50%; Acute ST-segment elevation myocardial infarction; Stents implanted within 10 mm proximal or distal to the target lesion; Aneurysm within 10 mm proximal or distal to the target lesion; There is target vessel distortion or severe calcification lesion, so balloon catheter fails to pass; Previous coronary artery bypass grafting; Evidence for extensive thrombus within target vessel; Evidence of heart failure by at least one of the following: a. Most recent LVEF ≤35%, or b. Current heart failure defined as dyspnea at rest (NYHA class IV assessed day of procedure), or c. Killip class ≥2 (post STEMI patients); Subjects with a life expectancy of ≤1 year; Subjects with stroke, peptic ulcer, or gastrointestinal bleeding within the past 6 months; Subjects with severe renal failure (eGFR<30ml/minute), failure to comply with angiography conditions; Subjects who are intolerance to aspirin and/or clopidogrel or ticagrelor or have contraindications; Subjects who are intolerance or allergic to heparin, contrast agent; Patients who are participating in the clinical trial of other drug or device without reaching the time limit of primary endpoint; Subjects who are not applicable to be enrolled by investigators due to other reasons.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yao technique<br>The following 2 treatment strategies are available. (1) DCB combined with provisional DES implantation 1-2 mm distally to the lesion ostium whenever this was required (DCB+pDES strategy). (2) DES implantation 1-2 mm distally to the lesion ostium followed by DCB (DES+DCB strategy). | Procedure: Drug-coated balloon combined with provisional drug-eluting stent implantation<br>* (1) DCB combined with provisional DES implantation 1-2 mm distally to the ostium lesion whenever this was required (DCB+pDES strategy). (2) DES implantation 1-2 mm distally to the ostium lesions followed by DCB treatment (DES+DCB strategy).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| late lumen loss | post-procedural minimum lumen diameter minus follow-up minimum lumen diameter. | 9 months follow-up | 
| major adverse cardiovascular events | include cardiac death, non-fatal myocardial infarction, and target lesion revascularization. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug-coated balloon, percutaneous coronary intervention, drug-eluting stent, Yao strategy