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Bifurcation LesionsNCT02325817

Bingo Drug-eluting Balloon in Bifurcation

A study testing Drug-eluting balloon and Uncoated ballloon in people with Bifurcation Lesions and Drug Eluting Balloon, run by Yinyi(Liaoning) Biotech Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Bifurcation Lesions, Drug Eluting Balloon
What is being tested?
Drug-eluting balloon and Uncoated ballloon
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
222 participants
Where
1 siteChina
Study dates
3 Dec 2014to 13 Jan 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • General Hospital of Shenyang Military Region

    Shenyang, Liaoning, 110016

Other trials in China

About this study

Official 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

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.

Being tested
Drug-eluting balloon, Uncoated ballloon
Keywords
Bifurcation Lesions, drug eluting balloon, paclitaxel, drug coated balloon

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Drug-eluting balloonDevice

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

  • Uncoated ballloonDevice

    Treat the side branch of bifurcation lesion with uncoated balloon

Study groups in NCT02325817
Study groupRoleWhat they receive
Drug-eluting balloonExperimentalTreat the side branch of bifurcation lesion with drug-eluting balloon
Receives: Device: Drug-eluting balloon
Uncoated balloonActive comparatorTreat the side branch of bifurcation lesion with uncoated balloon
Receives: Device: Uncoated ballloon

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Target lesion Stenosis (diameter, %)

    Measured: 9 months

Secondary outcomes (8)

  1. TLR

    Measured: 1, 6 and 9 months

  2. TVR

    Measured: 1, 6 and 9 months

  3. TLF

    cardiac death, target vessel MI, TLR

    Measured: 1, 6 and 9 months

  4. MACCE

    all-cause death, MI, stroke and TVR

    Measured: 1, 6 and 9 months

  5. All-cause death

    Measured: 1, 6 and 9 months

  6. Cardiac death

    Measured: 1, 6 and 9 months

  7. Non-fatal MI, thrombosis

    Measured: 1, 6 and 9 months

  8. Thrombosis

    Measured: 1, 6 and 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Dec 2014 (estimated)
  2. Study start3 Dec 2014
  3. Primary completion29 Nov 2016
  4. Study completion13 Jan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
222 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02325817
Sponsor's protocol ID
BEYOND
Status last verified
Aug 2017
First submitted
20 Dec 2014
Last updated
25 Aug 2017
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Jing QM, Zhao X, Han YL, Gao LL, Zheng Y, Li ZQ, Yang P, Cong HL, Gao CY, Jiang TM, Li H, Li JX, Wang DM, Wang G, Cong ZC, Zhang Z. A drug-eluting Balloon for the trEatment of coronarY bifurcatiON lesions in the side branch: a prospective multicenter ranDomized (BEYOND) clinical trial in China. Chin Med J (Engl). 2020 Apr 20;133(8):899-908. doi: 10.1097/CM9.0000000000000743.

    PubMed 32265425

Questions about this trial

What is this clinical trial studying?

A study testing Drug-eluting balloon and Uncoated ballloon in people with Bifurcation Lesions and Drug Eluting Balloon, run by Yinyi(Liaoning) Biotech Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target lesion Stenosis (diameter, %) (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02325817, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2017.

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