Bingo Drug-Coated Balloon in Real World

Coronary Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04234893
• Other study ID #: BEYOND Registry
• Status: Completed
• Start date: June 3, 2019
• Est. completion date: May 4, 2022

Study information

• Verified date: May 2022
• Source: Yinyi(Liaoning) Biotech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 805
• Est. completion date: May 4, 2022
• Est. primary completion date: June 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Constriction, Pathologic
• Coronary Artery Disease
• Coronary Artery Disease in Transplanted Heart Accelerated
• Coronary Disease
• Coronary Stenosis
• De Novo Stenosis
• Drug-coated Balloon
• Myocardial Ischemia

Locations

Country	Name	City	State
China	The Second Affiliated hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Yinyi(Liaoning) Biotech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiovascular Events	a composite endpoint of cardiovascular death, myocardial infarction, clinical driven target lesion revascularization	12 months
Secondary	device success	study device successfully dilate in the lesion without using bail-out stent	immediately after the procedure
Secondary	lesion success	residual diameter stenosis =30% and the TIMI flow grade 3 of the target lesion	immediately after the procedure
Secondary	clinical success	lesion success without in-hospital MACE	immediately after the procedure, up to 7 days
Secondary	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
Secondary	Target lesion failure	a composite endpoint of cardiovascular death, target vessel myocardial infarction, clinical driven target lesion revascularization	1, 6, 12 and 24 months
Secondary	Acute vessel closure		during the procedure and up to 24 hours
Secondary	Target lesion thrombosis		immediately after the procedure, up to 24 months