Bingo Drug-Coated Balloon in Real World

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-coated balloon in the real world.

Official Title
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A Registry Study of Bingo Drug-Coated Balloon in Real World

Conditions
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Coronary Stenosis, Drug-coated Balloon, De Novo Stenosis, Coronary Artery Disease in Transplanted Heart Accelerated

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or older, regardless of gender; Patients suitable for PCI with paclitaxel drug-coated balloon; Patients able to understand the purpose of this study, provide an informed consent and cooperate with clinical follow-up. Exclusion Criteria: General exclusion criteria Contraindications to PCI; In-stent restenosis; Life expectation less than 1 year; Patients not suitable for enrollment considered by investigator. Angiographic exclusion criteria: 1. Target lesion with the following conditions after pre-dilatation: Residual stenosis larger than 30% ; TIMI flow grade less than 3; Type C-F dissection (NHLBI grade).

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Drug-coated balloon<br>The Patients who treated with Bingo drug-coated balloon | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiovascular Events | a composite endpoint of cardiovascular death, myocardial infarction, clinical driven target lesion revascularization | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| device success | study device successfully dilate in the lesion without using bail-out stent | immediately after the procedure | 
| lesion success | residual diameter stenosis ≤30% and the TIMI flow grade 3 of the target lesion | immediately after the procedure | 
| clinical success | lesion success without in-hospital MACE | immediately after the procedure， up to 7 days | 
| rate of Target lesion revascularization | repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion | 1, 6, 12 and 24 months | 
| Target lesion failure | a composite endpoint of cardiovascular death, target vessel myocardial infarction, clinical driven target lesion revascularization | 1, 6, 12 and 24 months | 
| Acute vessel closure |  | during the procedure and up to 24 hours | 
| Target lesion thrombosis |  | immediately after the procedure， up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Stenosis, Percutaneous Coronary Intervention, Drug-coated Balloon, Drug eluting Balloon, Paclitaxel, De novo, Bifurcation, Coronary Artery Disease