Bingo Drug-Coated Balloon in Real World

N/ACompletedNCT04234893

Yinyi(Liaoning) Biotech Co., Ltd.805 enrolled

Overview

The purpose is to observe and evaluate the safety and efficacy of Bingo drug-coated balloon in the real world.

Study Type

OBSERVATIONAL

Enrollment

805

Conditions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 18 or older, regardless of gender; 2. Patients suitable for PCI with paclitaxel drug-coated balloon; 3. Patients able to understand the purpose of this study, provide an informed consent and cooperate with clinical follow-up. Exclusion Criteria: General exclusion criteria 1. Contraindications to PCI; 2. In-stent restenosis; 3. Life expectation less than 1 year; 4. Patients not suitable for enrollment considered by investigator. Angiographic exclusion criteria: 1\. Target lesion with the following conditions after pre-dilatation: 1. Residual stenosis larger than 30% ; 2. TIMI flow grade less than 3; 3. Type C-F dissection (NHLBI grade).

Locations (1)

The Second Affiliated hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Outcomes

Primary Outcomes

Major Adverse Cardiovascular Events

a composite endpoint of cardiovascular death, myocardial infarction, clinical driven target lesion revascularization

Time frame: 12 months

Secondary Outcomes

device success

study device successfully dilate in the lesion without using bail-out stent

Time frame: immediately after the procedure

lesion success

residual diameter stenosis ≤30% and the TIMI flow grade 3 of the target lesion

Time frame: immediately after the procedure

clinical success

lesion success without in-hospital MACE

Time frame: 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

Time frame: 1, 6, 12 and 24 months

Target lesion failure

a composite endpoint of cardiovascular death, target vessel myocardial infarction, clinical driven target lesion revascularization

Time frame: 1, 6, 12 and 24 months

Acute vessel closure

Time frame: during the procedure and up to 24 hours

Target lesion thrombosis

Time frame: immediately after the procedure， up to 24 months

Data from ClinicalTrials.gov

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