Coronary StenosisNCT04234893
Bingo Drug-Coated Balloon in Real World
An observational study of Coronary Stenosis and Drug-coated Balloon, run by Yinyi(Liaoning) Biotech Co., Ltd. at 1 site in China.
Trial summary
The purpose is to observe and evaluate the safety and efficacy of Bingo drug-coated balloon in the real world. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Stenosis, Drug-coated Balloon, De Novo Stenosis
- How many people
- 805 participants
- Where
- 1 siteChina
- Study dates
- 3 Jun 2019to 4 May 2022
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: PCI with Bingo drug-coated balloon
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 10Show fewer
- 1. 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).
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
About this study
Official title: A Registry Study of 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.
- Conditions
- Coronary Stenosis, Drug-coated Balloon, De Novo Stenosis, Coronary Artery Disease in Transplanted Heart Accelerated
- Keywords
- Coronary Stenosis, Percutaneous Coronary Intervention, Drug-coated Balloon, Drug eluting Balloon, Paclitaxel, De novo, Bifurcation, Coronary Artery Disease
- Medical subject headings
- Coronary Stenosis, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Drug-coated balloon | The Patients who treated with Bingo drug-coated balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events
a composite endpoint of cardiovascular death, myocardial infarction, clinical driven target lesion revascularization
Measured: 12 months
Secondary outcomes (7)
device success
study device successfully dilate in the lesion without using bail-out stent
Measured: immediately after the procedure
lesion success
residual diameter stenosis ≤30% and the TIMI flow grade 3 of the target lesion
Measured: immediately after the procedure
clinical success
lesion success without in-hospital MACE
Measured: immediately after the procedure， up to 7 days
rate of Target lesion revascularization
repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion
Measured: 1, 6, 12 and 24 months
Target lesion failure
a composite endpoint of cardiovascular death, target vessel myocardial infarction, clinical driven target lesion revascularization
Measured: 1, 6, 12 and 24 months
Acute vessel closure
Measured: during the procedure and up to 24 hours
Target lesion thrombosis
Measured: immediately after the procedure， up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start3 Jun 2019
- Primary completion4 Jun 2021
- Study completion4 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 805 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Yinyi(Liaoning) Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jian-an Wang, MD, PhD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04234893
- Sponsor's protocol ID
- BEYOND Registry
- Status last verified
- May 2022
- First submitted
- 6 Jan 2020
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registry Study of Bingo Drug-Coated Balloon in Real World
- ClinicalTrials.gov ID
- NCT04234893
- Acronym / sponsor ID
- BEYOND Registry
- Conditions
- Coronary Stenosis, Drug-coated Balloon, De Novo Stenosis, Coronary Artery Disease in Transplanted Heart Accelerated
- Keywords
- Coronary Stenosis, Percutaneous Coronary Intervention, Drug-coated Balloon, Drug eluting Balloon, Paclitaxel, De novo, Bifurcation, Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 805 participants (actual)
- Lead sponsor
- Yinyi(Liaoning) Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 4 Jun 2021 (actual)
- Study completion
- 4 May 2022 (actual)
- First posted
- 21 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose is to observe and evaluate the safety and efficacy of Bingo drug-coated balloon in the real world.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug-coated balloon | – | –The Patients who treated with Bingo drug-coated balloon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PCI with Bingo drug-coated balloon
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- General exclusion criteria
- Contraindications to PCI;
- In-stent restenosis;
- Life expectation less than 1 year;
- Patients not suitable for enrollment considered by investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major Adverse Cardiovascular Events
Time frame: 12 months
a composite endpoint of cardiovascular death, myocardial infarction, clinical driven target lesion revascularization
7 secondary outcomes
device success
Time frame: immediately after the procedure
lesion success
Time frame: immediately after the procedure
clinical success
Time frame: immediately after the procedure， up to 7 days
rate of Target lesion revascularization
Time frame: 1, 6, 12 and 24 months
Target lesion failure
Time frame: 1, 6, 12 and 24 months
Acute vessel closure
Time frame: during the procedure and up to 24 hours
Target lesion thrombosis
Time frame: immediately after the procedure， up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian-an Wang, MD, PhD principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Stenosis and Drug-coated 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 3 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 27 May 2022. 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?
Major Adverse Cardiovascular Events (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 May 2022; AzTrials last refreshed its copy on 6 Nov 2026.