Bingo Drug-Coated Balloon in Real World

NCT ID: NCT04234893

Last Updated: 2022-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

805 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-03

Study Completion Date

2022-05-04

Brief Summary

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

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Drug-coated balloon

The Patients who treated with Bingo drug-coated balloon

No interventions assigned to this group

Eligibility Criteria

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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

1. Contraindications to PCI;
2. In-stent restenosis;
3. Life expectation less than 1 year;
4. Patients not suitable for enrollment considered by investigator.


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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yinyi(Liaoning) Biotech Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jian-an Wang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

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The Second Affiliated hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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BEYOND Registry

Identifier Type: -

Identifier Source: org_study_id

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