CompletedNot Applicable

Bingo Drug-eluting Balloon in Bifurcation

China222 participantsStarted 2014-12-03

Plain-language summary

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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Target lesion Stenosis (diameter, %)

Timeframe: 9 months

Trial details

NCT IDNCT02325817

SponsorYinyi(Liaoning) Biotech Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-11-29

View on ClinicalTrials.gov More Bifurcation Lesions trials