Coronary Artery DiseaseDCB-MVDNCT06104033
Practice Change With Drug-coated Balloon in Patients With multiVessel Coronary Artery Disease
An observational study of Coronary Artery Disease and Multi Vessel Coronary Artery Disease, run by Bon-Kwon Koo at 1 site in South Korea.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 19 to 100 years
- Conditions the study is for
- Coronary Artery Disease, Multi Vessel Coronary Artery Disease
- What is being tested?
- drug-coated balloon and drug-eluting stent
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Sep 2023to 31 Oct 2026
- How long will I take part?
- 1 Year
- 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 19 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with multivessel coronary artery disease who undergo coronary intervention
Who may be able to join
- Age 19 or older
- 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
- Capable of understanding the risks and benefits of participating in the study and providing informed consent
Who cannot join
- Incapable of voluntarily providing informed consent
- Allergy or contraindication to aspirin, P2Y12 inhibitors, or components of drug-eluting stents
- Cardiogenic shock or cardiac arrest patients
- Patients with severe left ventricular systolic dysfunction (ejection fraction <30%)
- Patients for whom coronary artery bypass surgery is prioritized over coronary artery intervention
- Patients with severe valvular heart disease requiring open heart surgery
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Bon-Kwon Koo
Seoul
Bon-Kwon Koo, MD, PhD, +82-2-2072-2062, bkkoo@snu.ac.kr
About this study
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.
- Being tested
- drug-coated balloon, drug-eluting stent
- Keywords
- Coronary artery disease, Multivessel coronary artery disease, Percutaneous coronary intervention, Drug-coated balloon, Drug-eluting stent
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drug-coated balloonDevice
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.
drug-eluting stentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: drug-coated balloon; Device: drug-eluting stent | |
| DES only | The patient undergoes percutaneous coronary intervention with drug-eluting stents only in the coronary artery lesion. Receives: Device: drug-eluting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
The reclassification rate of the treatment strategy
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.
Measured: At the time of procedure
Secondary outcomes (18)
Rate of change in treatment pattern from drug-eluting stents to drug-coated balloons in target vessel therapy
Rate of change in treatment pattern from drug-eluting stents to drug-coated balloons in target vessel therapy
Measured: At the time of procedure
Rate of change in treatment pattern from drug-eluting stents to drug-coated balloons in target lesion therapy
Rate of change in treatment pattern from drug-eluting stents to drug-coated balloons in target lesion therapy
Measured: At the time of procedure
Cardiovascular death
Cardiovascular death
Measured: 1 year
All-cause death
All-cause death
Measured: 1 year
Non-fatal myocardial infarction (MI)
Non-fatal myocardial infarction (MI)
Measured: 1 year
Target vessel MI excluding periprocedural MI
Target vessel MI excluding periprocedural MI
Measured: 1 year
Target vessel MI including periprocedural MI
Target vessel MI including periprocedural MI
Measured: 1 year
Clinically indicated target lesion revascularization
Clinically indicated target lesion revascularization
Measured: 1 year
Clinically indicated target vessel revascularization
Clinically indicated target vessel revascularization
Measured: 1 year
Any revascularization
Any revascularization
Measured: 1 year
Vessel or stent thrombosis, definite or probable by Academic Research Consortium (ARC) definition
Vessel or stent thrombosis, definite or probable by Academic Research Consortium (ARC) definition
Measured: 1 year
Cardiovascular death or target vessel MI
Cardiovascular death or target vessel MI
Measured: 1 year
All-cause death or non-fatal MI
All-cause death or non-fatal MI
Measured: 1 year
Target vessel failure (TVF), including cardiovascular death, target vessel MI, or clinically indicated target vessel revascularization
Target vessel failure (TVF), including cardiovascular death, target vessel MI, or clinically indicated target vessel revascularization
Measured: 1 year
Target lesion failure (TLF), including cardiovascular death, target lesion MI, or clinically indicated target lesion revascularization
Target lesion failure (TLF), including cardiovascular death, target lesion MI, or clinically indicated target lesion revascularization
Measured: 1 year
Cardiovascular death, target vessel MI, or vessel or stent thrombosis
Cardiovascular death, target vessel MI, or vessel or stent thrombosis
Measured: 1 year
All-cause death, non-fatal MI, or clinically indicated target vessel revascularization
All-cause death, non-fatal MI, or clinically indicated target vessel revascularization
Measured: 1 year
Major bleeding events (BARC type 2, 3, or 5)
Major bleeding events (BARC type 2, 3, or 5)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start18 Sep 2023
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- 500 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Bon-Kwon Koo
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Hospital, St Vincent's Hospital, Uijeongbu St. Mary Hospital, Gachon University Gil Medical Center, Gangnam Severance Hospital, Kyunghee University Medical Center, Keimyung University Dongsan Medical Center, Inje University Ilsan Paik Hospital, Daegu Catholic University Medical Center, Sejong General Hospital, Seoul National University Bundang Hospital, Soonchunhyang University Hospital, Yeungnam University Hospital, Wonju Severance Christian Hospital, Ulsan University Hospital, Ewha Womans University Mokdong Hospital, Inje University, Chonnam National University Hospital, Chung-Ang University Gwangmyeong Hospital, Chung-Ang University Hospital, Ulsan Medical Center, Hanyang University Seoul Hospital, Jeju National University Hospital, KangWon National University Hospital, Uijeongbu Eulji University Hospital, Seoul St. Mary's Hospital, Gyeongsang National University Hospital, Severance Hospital, Chosun University Hospital, Kyungpook National University Hospital, Korea University Anam Hospital, Kyung Hee University Hospital at Gangdong, Ajou University School of Medicine
- Responsible party
- Sponsor-investigator, Bon-Kwon Koo, Seoul National University Hospital
- Investigators
- Bon-Kwon Koo, MD, PhD, Study chair, +82-2-2072-2062
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104033
- Sponsor's protocol ID
- 2306-138-1440
- Acronym
- DCB-MVD
- Status last verified
- Oct 2023
- First submitted
- 23 Oct 2023
- Last updated
- 27 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practice Change With Drug-coated Balloon in Patients With multiVessel Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT06104033
- Acronym / sponsor ID
- DCB-MVD / 2306-138-1440
- Keywords
- Coronary artery disease, Multivessel coronary artery disease, Percutaneous coronary intervention, Drug-coated balloon, Drug-eluting stent
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Bon-Kwon KooUniversity, hospital or other
- Collaborators
- Seoul National University Hospital, St Vincent's Hospital, Uijeongbu St. Mary Hospital, Gachon University Gil Medical Center, Gangnam Severance Hospital, Kyunghee University Medical Center, Keimyung University Dongsan Medical Center, Inje University Ilsan Paik Hospital, Daegu Catholic University Medical Center, Sejong General Hospital, Seoul National University Bundang Hospital, Soonchunhyang University Hospital, Yeungnam University Hospital, Wonju Severance Christian Hospital, Ulsan University Hospital, Ewha Womans University Mokdong Hospital, Inje University, Chonnam National University Hospital, Chung-Ang University Gwangmyeong Hospital, Chung-Ang University Hospital, Ulsan Medical Center, Hanyang University Seoul Hospital, Jeju National University Hospital, KangWon National University Hospital, Uijeongbu Eulji University Hospital, Seoul St. Mary's Hospital, Gyeongsang National University Hospital, Severance Hospital, Chosun University Hospital, Kyungpook National University Hospital, Korea University Anam Hospital, Kyung Hee University Hospital at Gangdong, Ajou University School of Medicine
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 27 Oct 2023 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hybrid strategy | – | Device: drug-coated balloon, Device: drug-eluting stentThe patient undergoes percutaneous coronary intervention with drug-coated balloons and drug-eluting stents or drug-coated balloons only in the coronary artery lesion. |
| DES only | – | Device: drug-eluting stentThe patient undergoes percutaneous coronary intervention with drug-eluting stents only in the coronary artery lesion. |
Who may qualify
- Ages
- 19 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with multivessel coronary artery disease who undergo coronary intervention
Key inclusion criteria (5 listed)
- Age 19 or older
- Multivessel coronary artery disease patients requiring coronary intervention
- Capable of understanding the risks and benefits of participating in the study and providing informed consent
Key exclusion criteria (7 listed)
- Incapable of voluntarily providing informed consent
- Allergy or contraindication to aspirin, P2Y12 inhibitors, or components of drug-eluting stents
- Cardiogenic shock or cardiac arrest patients
- Patients with severe left ventricular systolic dysfunction (ejection fraction <30%)
- Patients for whom coronary artery bypass surgery is prioritized over coronary artery intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| drug-coated balloonFor 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 | Hybrid strategy |
| drug-eluting stentWhen using drug-eluting stents, the latest 2nd generation drug-eluting stent (Synergy®, Boston Scientific, USA) should be used in accordance with the latest guidelines. | Device | DES only, Hybrid strategy |
Primary outcome
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.
18 secondary outcomes
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 lesion therapy
Time frame: At the time of procedure
Cardiovascular death
Time frame: 1 year
All-cause death
Time frame: 1 year
Non-fatal myocardial infarction (MI)
Time frame: 1 year
Target vessel MI excluding periprocedural MI
Time frame: 1 year
Target vessel MI including periprocedural MI
Time frame: 1 year
Clinically indicated target lesion revascularization
Time frame: 1 year
Clinically indicated target vessel revascularization
Time frame: 1 year
Any revascularization
Time frame: 1 year
Vessel or stent thrombosis, definite or probable by Academic Research Consortium (ARC) definition
Time frame: 1 year
Cardiovascular death or target vessel MI
Time frame: 1 year
All-cause death or non-fatal MI
Time frame: 1 year
Target vessel failure (TVF), including cardiovascular death, target vessel MI, or clinically indicated target vessel revascularization
Time frame: 1 year
Target lesion failure (TLF), including cardiovascular death, target lesion MI, or clinically indicated target lesion revascularization
Time frame: 1 year
Cardiovascular death, target vessel MI, or vessel or stent thrombosis
Time frame: 1 year
All-cause death, non-fatal MI, or clinically indicated target vessel revascularization
Time frame: 1 year
Major bleeding events (BARC type 2, 3, or 5)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
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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.
Bon-Kwon Koo, MD, PhD study chair
+82-2-2072-2062
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 Artery Disease and Multi Vessel Coronary Artery Disease, run by Bon-Kwon Koo at 1 site in South Korea.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 27 Oct 2023. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bon-Kwon Koo, MD, PhD (+82-2-2072-2062, bkkoo@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The reclassification rate of the treatment strategy (time frame: At the time of procedure). 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 Oct 2023.