Bingo Drug-Coated Balloon in Real World

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

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

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 805

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • The Second Affiliated Hospital of Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

PCI with Bingo drug-coated balloon

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Drug-coated balloon; The Patients who treated with Bingo drug-coated balloon

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yinyi(Liaoning) Biotech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2019
• Primary Completion (Actual): June 4, 2021
• Study Completion (Actual): May 4, 2022

Study Registration Dates

• First Submitted: January 6, 2020
• First Submitted That Met QC Criteria: January 15, 2020
• First Posted (Actual): January 21, 2020

Study Record Updates

• Last Update Posted (Actual): May 27, 2022
• Last Update Submitted That Met QC Criteria: May 26, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Percutaneous Coronary Intervention; Drug-coated Balloon; Bifurcation; Paclitaxel; Coronary Stenosis; De novo; Drug eluting Balloon
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Constriction, Pathologic; Coronary Stenosis
• Other Study ID Numbers: BEYOND Registry

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No