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Completed

NCT Number: NCT02325817

Bingo Drug-eluting Balloon in Bifurcation

The purpose is to observe and evaluate the safety and efficacy of Bingo drug-eluting balloon in the treatment of patients with bifurcation lesions of coronary artery.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Hospital of Shenyang Military Region

Shenyang, Liaoning, 110016, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or non-pregnant female ages 18-80 years old
  • Patients with asymptomatic myocardial ischemia symptom, stable or unstable angina pectoris or old myocardial infarction
  • Patients with bifurcation lesions of coronary artery observed by angiography.
  • The main branch of the vessels are suitable for PCI and stent therapy, and the side branch are intended to implement the kissing dilatation without considering dual stent implantation.
  • De Novo bifurcation lesions and diameter stenosis are not less than70%;
  • Referenced vessel diameters range from 1.25mm to 5.0mm, and lesions range are not more than 40mm
  • Residual stenosis are not more than 50% after predilatation;
  • Patients who understand the purpose of this trial, voluntary and sign informed consent.

Exclusion criteria

  • Heavily calcified lesions which cannot be dalatated successfully, and the lesions which are not suitable by balloon angioplasty
  • Left main coronary artery lesions without protection or related bifurcation lesions
  • Patients with severe heart failure symptoms (above NYHA III) or Left ventricular ejection fraction (LVEF) below 35% (ultrasound or left ventricular angiography)
  • Impairment of the renal function preoperative: Serum creatinine above 2.0mg/dl;
  • Patients with hemorrhagic tendency, the history of active digestive ulcers, the history of subarachnoid hemorrhage cerebral hemorrhage, antiplatelet and anticoagulant therapy contraindication and unable to anticoagulant therapy;
  • Patients who are allergic to aspirin, ticagrelor, clopidogrel, ticlopidine, heparin, contrast agent and paclitaxel, and cannot 1-year tolerate dual antiplatelet therapy (aspirin + clopidogrel or ticagrelor)
  • Patients whose expected lives are less than 1 year;
  • Patients who are considered to have poor compliance and cannot complete the trial in accordance with requirements.
  • In-stent restenosis lesions
  • Patients who are enrolled in this trial and need stent therapy due to vascular laceration or severe stenosis, and those patients are calculated as fall off cases.

Treatment and study plan

Drug-eluting balloon

Device

Treat the side branch of bifurcation lesion with drug-eluting balloon

Uncoated ballloon

Device

Treat the side branch of bifurcation lesion with uncoated balloon

Primary outcomes

  1. Target lesion Stenosis (diameter, %)

    Time frame: 9 months

Secondary outcomes

  1. TLR

    Time frame: 1, 6 and 9 months

  2. TVR

    Time frame: 1, 6 and 9 months

  3. TLF

    Time frame: 1, 6 and 9 months

    cardiac death, target vessel MI, TLR

  4. MACCE

    Time frame: 1, 6 and 9 months

    all-cause death, MI, stroke and TVR

  5. All-cause death

    Time frame: 1, 6 and 9 months

  6. Cardiac death

    Time frame: 1, 6 and 9 months

  7. Non-fatal MI, thrombosis

    Time frame: 1, 6 and 9 months

  8. Thrombosis

    Time frame: 1, 6 and 9 months

Sponsors and collaborators

Lead sponsor

Yinyi(Liaoning) Biotech Co., Ltd.

Industry

Registry information

Official study title

A Multicenter, Superior, Randomized Controlled Clinical Trial to Observe the Safety and Efficacy of Bingo Drug-eluting Balloon vs. Yinyi Balloon Dilatation Catheter in the Treatment of Patients With Bifurcation Stenosis Lesions of Coronary Artery

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Dec 25, 2014
Registry last updated
Aug 25, 2017

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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