Bingo Drug-Coated Balloon in Real World

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04234893

Enrollment

805

Registered

2020-01-21

Start date

2019-06-03

Completion date

2022-05-04

Last updated

2022-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Coronary Stenosis, Percutaneous Coronary Intervention, Drug-coated Balloon, Drug eluting Balloon, Paclitaxel, De novo, Bifurcation, Coronary Artery Disease

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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 thrombosis	immediately after the procedure， up to 24 months	—
Target lesion failure	1, 6, 12 and 24 months	a composite endpoint of cardiovascular death, target vessel myocardial infarction, clinical driven target lesion revascularization
Acute vessel closure	during the procedure and up to 24 hours	—
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

Countries

China

Outcome results