Bingo Drug-eluting Balloon in Bifurcation

Study Overview
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Brief Summary
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The purpose is to observe and evaluate the safety and efficacy of Bingo drug-eluting balloon in the treatment of patients with bifurcation lesions of coronary artery.

Official Title
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A Multicenter, Superior, Randomized Controlled Clinical Trial to Observe the Safety and Efficacy of Bingo Drug-eluting Balloon vs. Yinyi Balloon Dilatation Catheter in the Treatment of Patients With Bifurcation Stenosis Lesions of Coronary Artery

Conditions
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Bifurcation Lesions, Drug Eluting Balloon

Intervention / Treatment
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* Device: Drug-eluting balloon
* Device: Uncoated ballloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or non-pregnant female ages 18-80 years old Patients with asymptomatic myocardial ischemia symptom, stable or unstable angina pectoris or old myocardial infarction Patients with bifurcation lesions of coronary artery observed by angiography. The main branch of the vessels are suitable for PCI and stent therapy, and the side branch are intended to implement the kissing dilatation without considering dual stent implantation. De Novo bifurcation lesions and diameter stenosis are not less than70%; Referenced vessel diameters range from 1.25mm to 5.0mm, and lesions range are not more than 40mm Residual stenosis are not more than 50% after predilatation; Patients who understand the purpose of this trial, voluntary and sign informed consent. Exclusion Criteria: Heavily calcified lesions which cannot be dalatated successfully, and the lesions which are not suitable by balloon angioplasty Left main coronary artery lesions without protection or related bifurcation lesions Patients with severe heart failure symptoms (above NYHA III) or Left ventricular ejection fraction (LVEF) below 35% (ultrasound or left ventricular angiography) Impairment of the renal function preoperative: Serum creatinine above 2.0mg/dl； Patients with hemorrhagic tendency, the history of active digestive ulcers, the history of subarachnoid hemorrhage cerebral hemorrhage, antiplatelet and anticoagulant therapy contraindication and unable to anticoagulant therapy; Patients who are allergic to aspirin, ticagrelor, clopidogrel, ticlopidine, heparin, contrast agent and paclitaxel, and cannot 1-year tolerate dual antiplatelet therapy (aspirin + clopidogrel or ticagrelor) Patients whose expected lives are less than 1 year; Patients who are considered to have poor compliance and cannot complete the trial in accordance with requirements. In-stent restenosis lesions Patients who are enrolled in this trial and need stent therapy due to vascular laceration or severe stenosis, and those patients are calculated as fall off cases.

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: Drug-eluting balloon<br>Treat the side branch of bifurcation lesion with drug-eluting balloon | Device: Drug-eluting balloon<br>* Treat the side branch of bifurcation lesion with drug-eluting balloon<br>|
| Active Comparator: Uncoated balloon<br>Treat the side branch of bifurcation lesion with uncoated balloon | Device: Uncoated ballloon<br>* Treat the side branch of bifurcation lesion with uncoated balloon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target lesion Stenosis (diameter, %) |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TLR |  | 1, 6 and 9 months | 
| TVR |  | 1, 6 and 9 months | 
| TLF | cardiac death, target vessel MI, TLR | 1, 6 and 9 months | 
| MACCE | all-cause death, MI, stroke and TVR | 1, 6 and 9 months | 
| All-cause death |  | 1, 6 and 9 months | 
| Cardiac death |  | 1, 6 and 9 months | 
| Non-fatal MI, thrombosis |  | 1, 6 and 9 months | 
| Thrombosis |  | 1, 6 and 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bifurcation Lesions, drug eluting balloon, paclitaxel, drug coated balloon