Bingo Drug-eluting Balloon Versus a Drug-eluting Stent for Coronary Bifurcation Lesions

May 28, 2024 updated by: Yinyi(Liaoning) Biotech Co., Ltd.

Bingo Drug-eluting Balloon Versus a Drug-eluting Stent for Coronary Bifurcation Lesions: a Prospective, Multi-center, Randomized, Non-inferiority Trial

Bingo drug-eluting balloon versus a drug-eluting stent for coronary bifurcation lesions: a prospective, multi-center, randomized, non-inferiority trial

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
218

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Clinical Inclusion Criteria:

  1. Age 18 to 80
  2. Patients with chronic stable coronary artery disease, or unstable angina, or NSTEMI (Grace score<140), or STEMI more than one week
  3. Subjects suitable for PCI
  4. Subjects understand the trial purpose, volunteer to participate and sign informed consent form

Angiographic Inclusion Criteria (by visual):

  1. One coronary de novo bifurcation lesion (including Medina classification: 1,1,1 / 1,0,1 / 0,1,1, which need to be treated for both main and side branches)
  2. The reference vessel diameter of main branch is between 2.5 to 4.0 mm, length ≤ 30 mm. Before lesion preparation, lesion diameter stenosis shall be ≥70%, or ≥50% with evidence of myocardial ischemia
  3. The reference vessel diameter of side branch is ≥2.0 mm, length <20 mm. Before lesion preparation, lesion diameter stenosis shall be ≥70%
  4. No more than 3 lesions on the non-target vessel in the same operation, and shall be successfully treated before the target vessel
  5. No more than 1 non-target lesion on the target vessel in the same operation, and shall be successfully prepared before the target lesion (successful preparation of non-target lesion is defined as residual stenosis ≤30% and TIMI flow 3). After randomization, the non-target lesion shall be treated according to the assigned group, for the experimental group, using the experimental DCB is recommended; for the control group, using DES is recommended; Independent lesion on the same coronary artery is defined as interval >5 mm
  6. The target lesions of main and side branches must be successfully prepared (successful preparation is defined as: residual stenosis ≤30% , without NHLBI type C or above dissection, and TIMI flow 3)

Clinical Exclusion Criteria:

  1. Severe heart failure (NYHA IV), cardiogenic shock or severe valvular heart disease
  2. Left ventricular ejection fraction ≤35%
  3. Severe renal insufficiency (eGFR <30 ml/min)
  4. Severe liver insufficiency (glutamate transaminase (ALT) or glutamate transaminase (AST) >3 times the upper limit of normal)
  5. Pregnant women or planned pregnancy
  6. With a known allergy to heparin, contrast agent, paclitaxel and everolimus
  7. Unable to receive antiplatelet agents and anticoagulants, bleeding tendency or coagulopathy
  8. Life expectancy does not exceed 1 year
  9. Participating in other drug or device clinical trials without reaching the primary endpoint
  10. Subjects who had undergone coronary revascularization in the last 6 months
  11. Subjects not eligible by the investigator for other reasons

Angiographic Exclusion Criteria (by visual):

  1. In-stent restenosis lesion
  2. Left main bifurcation lesion
  3. Chronic total occlusive lesion
  4. Target vessel is severely distorted, angulated or calcified, which is anticipated difficult to cross for balloon or stent
  5. Target lesion remains significant residual thrombus after preparation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: drug-eluting balloon
Treat the main vessel and side branch of bifurcation lesion with drug-eluting balloon
Device: Bingo® Paclitaxel coated balloon
Treat the main vessel and side branch of bifurcation lesion with drug-eluting balloon
Active Comparator: drug-eluting stent
Treat the main vessel of bifurcation lesion with drug-eluting stent, and treat the side branch with uncoated balloon or drug-eluting stent
Device: Xience® Alpine Everolimus Eluting Coronary Stent System
Treat the main vessel of bifurcation lesion with drug-eluting stent, and treat the side branch with uncoated balloon or drug-eluting stent

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
in-segment late lumen loss in main branch
Time Frame: 9 months
use quantitative coronary angiography by an independent core laboratory
9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Procedure success rates
Time Frame: up to 7 days in-hospital
include device success, lesion success and clinical success
up to 7 days in-hospital
Minimal lumen diameter
Time Frame: 9 months
use quantitative coronary angiography by an independent core laboratory
9 months
Diameter stenosis
Time Frame: 9 months
use quantitative coronary angiography by an independent core laboratory
9 months
Dissection and type
Time Frame: 9 months
use quantitative coronary angiography by an independent core laboratory
9 months
in-segment late lumen loss in side branch
Time Frame: 9 months
use quantitative coronary angiography by an independent core laboratory
9 months
Binary restenosis
Time Frame: 9 months
use quantitative coronary angiography by an independent core laboratory
9 months
Target lesion failure
Time Frame: 1, 6, 9 and 12 months
include cardiac death, target vessel myocardial infarction, clinically driven target lesion revascularization
1, 6, 9 and 12 months
Target lesion thrombosis
Time Frame: 1, 6, 9 and 12 months
include acute, sub-acute, late and very late period
1, 6, 9 and 12 months
BARC bleeds
Time Frame: 1, 6, 9 and 12 months
type 2, 3 or 5
1, 6, 9 and 12 months
Stroke
Time Frame: 1, 6, 9 and 12 months
any stroke
1, 6, 9 and 12 months
Myocardial infarction
Time Frame: Peri-operation and 12 months
include peri-operation and 12 months
Peri-operation and 12 months
Death
Time Frame: 1, 6, 9 and 12 months
include cardiac and all-cause death
1, 6, 9 and 12 months
Major Adverse Cardiovascular Events
Time Frame: 1, 6, 9 and 12 months
composite endpoint with death, myocardial infarction and target vessel revascularization
1, 6, 9 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yinyi(Liaoning) Biotech Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LNYY2024001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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