Bingo Drug-Coated Balloon in Real World

Completed

• Conditions: Coronary Stenosis; De Novo Stenosis; Drug-coated Balloon; Coronary Artery Disease in Transplanted Heart Accelerated

• Registration Number: NCT04234893
• Lead Sponsor: Yinyi(Liaoning) Biotech Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-03
• Study First Submitted: 2020-01-06
• Study First Submitted QC: 2020-01-15
• Study First Posted: 2020-01-21
• Primary Completion: 2021-06-04
• Status Verified: 2022-05
• Study Completion: 2022-05-04
• Last Update Submitted: 2022-05-26
• Last Update Posted: 2022-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 805

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:

2. Residual stenosis larger than 30% ;

3. TIMI flow grade less than 3;

4. Type C-F dissection (NHLBI grade).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiovascular Events	12 months	a composite endpoint of cardiovascular death, myocardial infarction, clinical driven target lesion revascularization

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Second Affiliated hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China