Practice Change With Drug-coated Balloon in Patients With multiVessel Coronary Artery Disease (DCB-MVD)

October 23, 2023 updated by: Bon-Kwon Koo
This study is a prospective, multicenter, open-label, observational study to investigate the impact of using drug-coated balloons (DCBs) in the treatment of coronary artery lesions in patients with multivessel coronary artery disease (MVD), as opposed to the default strategy of using only drug-eluting stents (DES). The investigators aim to assess changes in clinical practice towards a hybrid treatment strategy (DES and DCB) and its effects on clinical outcomes.

Study Overview

Status

Status

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

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.
500

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Bon-Kwon Koo, MD, PhD
  • Phone Number: +82-2-2072-2062
  • Email: bkkoo@snu.ac.kr

Study Locations

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

Sampling Method

Non-Probability Sample

Study Population

Patients with multivessel coronary artery disease who undergo coronary intervention

Description

Inclusion Criteria:

  1. Age 19 or older

  2. Multivessel coronary artery disease patients requiring coronary intervention

    • Stenosis of 2 or more major coronary arteries or major coronary artery branches (Vessel size ≥2.5mm) with diameter stenosis ≥50% or fractional flow reserve ≤0.80 requiring repeat revascularization
    • Having stenotic lesions requiring revascularization with a vessel size of 2.5mm to 3.0mm
  3. Capable of understanding the risks and benefits of participating in the study and providing informed consent

Exclusion Criteria:

  1. Incapable of voluntarily providing informed consent
  2. Allergy or contraindication to aspirin, P2Y12 inhibitors, or components of drug-eluting stents
  3. Cardiogenic shock or cardiac arrest patients
  4. Patients with severe left ventricular systolic dysfunction (ejection fraction <30%)
  5. Patients for whom coronary artery bypass surgery is prioritized over coronary artery intervention
  6. Patients with severe valvular heart disease requiring open heart surgery
  7. Pregnant or lactating women

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Hybrid strategy
The patient undergoes percutaneous coronary intervention with drug-coated balloons and drug-eluting stents or drug-coated balloons only in the coronary artery lesion.
Device: drug-coated balloon
For the procedure, the drug-coated balloon (Agent®, Boston Scientific, USA) that can be used for both de-novo coronary lesions and in-stent restenosis lesions is used.
Device: drug-eluting stent
When using drug-eluting stents, the latest 2nd generation drug-eluting stent (Synergy®, Boston Scientific, USA) should be used in accordance with the latest guidelines.
DES only
The patient undergoes percutaneous coronary intervention with drug-eluting stents only in the coronary artery lesion.
Device: drug-eluting stent
When using drug-eluting stents, the latest 2nd generation drug-eluting stent (Synergy®, Boston Scientific, USA) should be used in accordance with the latest guidelines.

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
The reclassification rate of the treatment strategy
Time Frame: At the time of procedure
The reclassification rate according to the change in treatment approach from the default strategy of using only drug-eluting stents (DES-only) to the hybrid strategy of using both drug-coated balloons and drug-eluting stents in the treatment of multivessel coronary artery disease.
At the time of 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
Cardiovascular death
Time Frame: 1 year
Cardiovascular death
1 year
Rate of change in treatment pattern from drug-eluting stents to drug-coated balloons in target vessel therapy
Time Frame: At the time of procedure
Rate of change in treatment pattern from drug-eluting stents to drug-coated balloons in target vessel therapy
At the time of procedure
Rate of change in treatment pattern from drug-eluting stents to drug-coated balloons in target lesion therapy
Time Frame: At the time of procedure
Rate of change in treatment pattern from drug-eluting stents to drug-coated balloons in target lesion therapy
At the time of procedure
All-cause death
Time Frame: 1 year
All-cause death
1 year
Non-fatal myocardial infarction (MI)
Time Frame: 1 year
Non-fatal myocardial infarction (MI)
1 year
Target vessel MI excluding periprocedural MI
Time Frame: 1 year
Target vessel MI excluding periprocedural MI
1 year
Target vessel MI including periprocedural MI
Time Frame: 1 year
Target vessel MI including periprocedural MI
1 year
Clinically indicated target lesion revascularization
Time Frame: 1 year
Clinically indicated target lesion revascularization
1 year
Clinically indicated target vessel revascularization
Time Frame: 1 year
Clinically indicated target vessel revascularization
1 year
Any revascularization
Time Frame: 1 year
Any revascularization
1 year
Vessel or stent thrombosis, definite or probable by Academic Research Consortium (ARC) definition
Time Frame: 1 year
Vessel or stent thrombosis, definite or probable by Academic Research Consortium (ARC) definition
1 year
Cardiovascular death or target vessel MI
Time Frame: 1 year
Cardiovascular death or target vessel MI
1 year
All-cause death or non-fatal MI
Time Frame: 1 year
All-cause death or non-fatal MI
1 year
Target vessel failure (TVF), including cardiovascular death, target vessel MI, or clinically indicated target vessel revascularization
Time Frame: 1 year
Target vessel failure (TVF), including cardiovascular death, target vessel MI, or clinically indicated target vessel revascularization
1 year
Target lesion failure (TLF), including cardiovascular death, target lesion MI, or clinically indicated target lesion revascularization
Time Frame: 1 year
Target lesion failure (TLF), including cardiovascular death, target lesion MI, or clinically indicated target lesion revascularization
1 year
Cardiovascular death, target vessel MI, or vessel or stent thrombosis
Time Frame: 1 year
Cardiovascular death, target vessel MI, or vessel or stent thrombosis
1 year
All-cause death, non-fatal MI, or clinically indicated target vessel revascularization
Time Frame: 1 year
All-cause death, non-fatal MI, or clinically indicated target vessel revascularization
1 year
Major bleeding events (BARC type 2, 3, or 5)
Time Frame: 1 year
Major bleeding events (BARC type 2, 3, or 5)
1 year

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.
Bon-Kwon Koo

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Seoul St. Mary's Hospital
Chonnam National University Hospital
Seoul National University Hospital
Ulsan University Hospital
Korea University Anam Hospital
Seoul National University Bundang Hospital
Gachon University Gil Medical Center
Ajou University School of Medicine
Daegu Catholic University Medical Center
Kyungpook National University Hospital
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Inje University
Gyeongsang National University Hospital
Yeungnam University Hospital
Gangnam Severance Hospital
Severance Hospital
Ewha Womans University Mokdong Hospital
Keimyung University Dongsan Medical Center
Kyung Hee University Hospital at Gangdong
Soonchunhyang University Hospital
St Vincent's Hospital
Hanyang University Seoul Hospital
Jeju National University Hospital
Wonju Severance Christian Hospital
Kyunghee University Medical Center
KangWon National University Hospital
Chosun University Hospital
Uijeongbu St. Mary Hospital
Inje University Ilsan Paik Hospital
Ulsan Medical Center
Chung-Ang University Gwangmyeong Hospital
Bucheon Sejong Hospital
Uijeongbu Eulji Medical Center, Eulji University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Bon-Kwon Koo, MD, PhD, +82-2-2072-2062

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.
September 18, 2023

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.
August 31, 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.
October 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).
October 23, 2023

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.
October 23, 2023

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.
October 27, 2023

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.
October 27, 2023

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.
October 23, 2023

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.
October 1, 2023

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.
  • 2306-138-1440

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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