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Completed

NCT Number: NCT04234893

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.

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Key information

Conditions

Coronary Stenosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Artery Disease in Transplanted Heart Accelerated Coronary Disease De Novo Stenosis Drug-coated Balloon Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 or older, regardless of gender;
  • Patients suitable for PCI with paclitaxel drug-coated balloon;
  • Patients able to understand the purpose of this study, provide an informed consent and cooperate with clinical follow-up.

Exclusion criteria

General exclusion criteria

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

Angiographic exclusion criteria:

  • Target lesion with the following conditions after pre-dilatation:
  • Residual stenosis larger than 30% ;
  • TIMI flow grade less than 3;
  • Type C-F dissection (NHLBI grade).

Treatment and study plan

Primary outcomes

  1. Major Adverse Cardiovascular Events

    Time frame: 12 months

    a composite endpoint of cardiovascular death, myocardial infarction, clinical driven target lesion revascularization

Secondary outcomes

  1. device success

    Time frame: immediately after the procedure

    study device successfully dilate in the lesion without using bail-out stent

  2. lesion success

    Time frame: immediately after the procedure

    residual diameter stenosis ≤30% and the TIMI flow grade 3 of the target lesion

  3. clinical success

    Time frame: immediately after the procedure， up to 7 days

    lesion success without in-hospital MACE

  4. rate of Target lesion revascularization

    Time frame: 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

  5. Target lesion failure

    Time frame: 1, 6, 12 and 24 months

    a composite endpoint of cardiovascular death, target vessel myocardial infarction, clinical driven target lesion revascularization

  6. Acute vessel closure

    Time frame: during the procedure and up to 24 hours

  7. Target lesion thrombosis

    Time frame: immediately after the procedure， up to 24 months

Sponsors and collaborators

Lead sponsor

Yinyi(Liaoning) Biotech Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Jan 21, 2020
Registry last updated
May 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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