Clinical Trial on Safety and Efficacy of Drug-coated Balloon in Treatment of Coronary Bifurcation Lesions (BJDCB-BIF)

March 21, 2022 updated by: Xue Yu, Beijing Hospital
The objective of this study is to evaluate the safety and efficacy of paclitaxel-coated balloon in treatment of coronary bifurcation lesions. This is a feasible study to demonstrate the noninferiority of paclitaxel Drug-coated balloon(DCB) only strategy for bifurcation lesions when compared with traditional single drug eluting stent(DES) strategy, so as to simplify the procedure for treatment of coronary bifurcation lesions and extending the clinical indications of paclitaxel DCB in China.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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.

Detailed Description

Paclitaxel DCB is designed to release anti-proliferative agents to the whole lesion rapidly and homogenously to inhibit excessive neointima proliferation and is associated with rapid healing of endothelium. As a result, DCB therapy reduces the risk of coronary thrombosis. Since only 1 to 3 months duration of dual anti-platelet therapy is required, the bleeding risk associated with prolonged dual anti-platelet therapy (DAPT) is reduced by DCB. Furthermore, there is no permanent residue of foreign bodies in the blood vessels after DCB procedure and this advantage completely eliminates adverse events associated with allergic reactions to metal, polymer and stent fracture. For side branch(SB) with a relatively small lumen in bifurcation lesions, DCB may neglect the lumen loss due to stent scaffolds and cause much less late lumen loss (LLL) than stent therapy does. For main branch(MB), no jailed SBs by the stent and the rate of SB stenosis or even occlusion will be greatly reduced.

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 (Actual)

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.
80

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Beijing Hospital

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient-related criteria：

    • Patients with stable angina, unstable angina, old myocardial infarction or evidence of asymptomatic myocardial ischemia and consent to receive coronary intervention therapy;
    • Aged between 18 and 80 years;
    • Consent to receive angiographic follow up at 9 months and clinical follow up at 30 days, 6, 9, 12 and 24 months.

  • Lesion-related criteria：

    • Target lesions of Medina (0,1,1), (1,0,1) or (1,1,1) primary coronary bifurcation lesions without previous intervention therapy;
    • MB reference vessel diameter between 2.5 mm and 3.5 mm and length ≤30mm; SB reference vessel diameter between 2.0 mm and 3.0 mm and length ≤22 mm;
    • Pre-operative vessel diameter stenosis must ≥70% or ≥50% associated with local ischemia;
    • After lesion predilation, no dissection is seen, or type A/B dissection can be seen, residual stenosis ≤30% and TIMI(thrombolysis in myocardial infarction) grade 3 flow;
    • The distance between other lesions requiring intervention therapy and the target lesion must >10mm ;
    • Only one drug-eluting balloon or drug-eluting stent is used in treatment of MB and SB lesions.

Exclusion Criteria:

  • Patient-related criteria：

    • Myocardial infarction in the previous week;
    • Severe congestive heart failure[LVEF <30% or NYHA( New York Heart Association) III/IV)]
    • Severe valvular heart disease;
    • Pregnant or breastfeeding women;
    • Life expectancy no more than 1 year or factors causing difficulties in clinical follow up;
    • Bleeding predisposition, contraindications of anticoagulants or antiplatelet agents;
    • Intolerance to aspirin and/or clopidogrel;
    • Known intolerance or allergy to heparin, contrast agents, paclitaxel, iopromide, rapamycin, polylactic acid-glycolic acid copolymer, Co-Cr alloy or platinum-chromium alloy;
    • Leukopenia or thrombopenia;
    • A history of peptic ulcer or GI bleeding in the previously;
    • Stroke within 6 months prior to the operation;
    • A history of severe hepatic or renal failure.

  • Lesion-related criteria ：

    • Extensive thrombosis in the target vessel;
    • Percutaneous coronary intervention of the graft vessel;
    • Chronic total occlusions (pre-operative TIMI grade 0 flow);
    • Left main branch lesions and /or three-vessel lesions requiring treatment;
    • Lesions that are not indications of PTCA(percutaneous transluminal coronary angiography) or other intervention therapy.

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: Paclitaxel DCB for MB and/or SB
Balloon/vessel diameter ratio 0.8-1.0, 8-10 ATM(atmosphere), lasting for >30 seconds
Device: Paclitaxel DCB
Balloon/vessel diameter ratio 0.8-1.0, 8-10 ATM, lasting for >30 seconds. If quantitative coronary angiography determines residual stenosis ≤ 30% , it is considered to be a successful operation.
Active Comparator: DES in MB
with regular techniques
Device: DES
MB should be sufficiently predilated to facilitate the positioning of the stent and the stent residual stenosis should be ≤10% to be a successful operation.

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
QCA(quantitative coronary analysis) of efficacy of DCB
Time Frame: Follow-up coronary angiography at 9 months after the procedure
late lumen loss, minimal lumen diameter
Follow-up coronary angiography at 9 months after the procedure

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
device-related ischemic events
Time Frame: Clinical follow up at 30 days, 6, 9, 12 and 24 months after the procedure
including cardiovascular death, target vessel related myocardial infarction and ischemia-driven revascularization
Clinical follow up at 30 days, 6, 9, 12 and 24 months after the procedure
patient-related ischemic events
Time Frame: Clinical follow up at 30 days, 6, 9, 12 and 24 months after the operation
all myocardial infarction , any revascularization and all-cause death
Clinical follow up at 30 days, 6, 9, 12 and 24 months after the operation
ARC（Academic Research Consortium） defined target vessel thrombus events
Time Frame: Clinical follow up at 30 days, 6, 9, 12 and 24 months after the operation
definite, probable and possible target vessel thrombus
Clinical follow up at 30 days, 6, 9, 12 and 24 months after the operation

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.
Beijing Hospital

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 (Actual)

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.
November 16, 2017

Primary Completion (Actual)

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.
November 30, 2019

Study Completion (Actual)

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.
February 28, 2021

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).
July 15, 2017

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.
July 17, 2017

First Posted (Actual)

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.
July 21, 2017

Study Record Updates

Last Update Posted (Actual)

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.
March 22, 2022

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.
March 21, 2022

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.
March 1, 2022

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.
  • BJYY121-2016003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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