Multivessel Coronary Artery DiseaseNCT01947439
Comparison of the Biolimus A9-eluting Stent With the Zotarolimus -Eluting Stent in Multi-vessel PCI
A study testing Percutaneous Coronary Intervention in people with Multivessel Coronary Artery Disease, run by Keimyung University Dongsan Medical Center at 9 sites in South Korea.
Trial summary
The risk of restenosis in the treatment of coronary artery disease has significantly lessened thanks to the introduction of Drug eluting stent. Yet, debates on the efficacy and safety of stents in complex lesions or patients have been circulated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multivessel Coronary Artery Disease
- What is being tested?
- Percutaneous Coronary Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 932 participants
- Where
- 9 sitesSouth Korea
- Study dates
- Mar 2013to Jun 2021
- Phase
- Interventional
- 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
Who may be able to join
- patients who need multi-vessel stenting with multi-vessel disease
- patients with signed informed consent
Who cannot join
- known contraindication to any of the following medications: Aspirin,clopidogrel, heparin, contrast agent, Biolimus or Zotarolimus group
- Cardiogenic shock
- Pregnant women or women with potential childbearing
- End-stage diseases with life expectancy shorter than 2 years
- patients with other Drug eluting stents implanted
- Patients requiring modification of antiplatelet agents for planned major surgery within the first 12 months after the enrollment.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
South Korea9 sites
Kosin University Hospital
Busan
Daegu Catholic University Medical Center
Daegu
Daegu Fatima Hospital
Daegu
KyungPook National University Hospital
Daegu
Yeungnam University Hospital
Daegu
Inje University Ilsan Paik Hospital
Ilsan, Kyeongki
Chonnam National University Hospital
Kwangju, Chonnam
Seoul National University Hospital
Seoul
Ulsan University Hospital
Ulsan, Gyeongsangbuk-do
About this study
Official title: Prospective,Multicenter Study of Randomized Comparison of the Biolimus A9-eluting Stent With the Zotarolimus-eluting Stent in Multi-vessel PCI
The risk of restenosis in the treatment of coronary artery disease has significantly lessened thanks to the introduction of Drug eluting stent.
Yet, debates on the efficacy and safety of stents in complex lesions or patients have been circulated.
Recently, PCI in multiple lesions is universally performed with the development of effective stents in various kinds in the clinics.
However, a randomized study is rare for multi-vessel coronary artery disease in real procedural environments.
The primary purpose of this study is to evaluate the clinical progress of biolimus A9-eluting stent and zotarolimus-eluting stent in multi-vessel coronary artery disease.
Read the detailed description
The patients who need multi-vessel stenting with multi-vessel coronary artery disease will be enrolled.Each randomization of the enrolled subjects will be done 1:1 (biolimus A9-eluting stent : zotarolimus-eluting stent). Randomization will be stratified by two factors: Diabetes mellitus and Acute coronary syndrome.Clinical follow-up will occur at the following time points; 1 month, 1 year and 2 years.
- Conditions
- Multivessel Coronary Artery Disease
- Being tested
- Percutaneous Coronary Intervention
- Keywords
- multivessel stenting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Coronary InterventionProcedure or surgery
Also called -Resolute Integrity, -Biomatrix, -Biomatrix Flex
Percutaneous Transluminal coronary angioplasty and Intervention will be performed in both of randomized groups of biolimus A9 eluting stent and zotarolimus eluting stent
| Study group | Role | What they receive |
|---|---|---|
| Biolimus A9 eluting stent | Experimental | biolimus A9 stent( Biomatrix or Biomatrix Flex) will be placed in under Percutaneous Coronary Intervention. Receives: Procedure: Percutaneous Coronary Intervention |
| Zotarolimus-eluting stent | Active comparator | zotarolimus eluting stent (Resolute Integrity) will be placed in under Percutaneous Coronary Intervention. Receives: Procedure: Percutaneous Coronary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year composite end points
All cause death, non fatal myocardial infarction, any revascularization
Measured: up to 2 years
Secondary outcomes (8)
All cause death
All cause death
Measured: up to 2 years
non-cardiac death
non-cardiac death
Measured: up to 2 years
cardiac death
cardiac death
Measured: up to 2 years
non fatal myocardial infarction
non fatal myocardial infarction
Measured: up to 2 years
Any revascularization
Any revascularization
Measured: up to 2 years
Target lesion revascularization
Target lesion revascularization
Measured: up to 2 years
Target vessel revascularization
Target vessel revascularization
Measured: up to 2 years
stent thrombosis
stent thrombosis
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startMar 2013
- Primary completionJun 2021
- Study completionJun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multivessel 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 932 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NAM, Chang-Wook, Keimyung University Dongsan Medical Center
- Investigators
- Chang-Wook Nam, Postdoctoral, Principal investigator, Keimyung University Dongsan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947439
- Sponsor's protocol ID
- BATTLE IN MULTI
- Status last verified
- Aug 2021
- First submitted
- 12 Sep 2013
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee CH, Lee HJ, Chung TW, Lee S, Hwang J, Kim IC, Cho YK, Yoon HJ, Hur SH, Kim JY, Kim YS, Jang WS, Lee JH, Kim W, Lee JB, Hong YJ, Heo JH, Lee BR, Doh JH, Shin ES, Koo BK, Nam CW. Comparison of Thick Biolimus A9-Eluting Stent and Thin Zotarolimus-Eluting Stent in Multi-Vessel Percutaneous Coronary Intervention. Korean Circ J. 2025 May;55(5):396-407. doi: 10.4070/kcj.2024.0101. Epub 2025 Feb 17.
PubMed 40097279
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective,Multicenter Study of Randomized Comparison of the Biolimus A9-eluting Stent With the Zotarolimus-eluting Stent in Multi-vessel PCI
- ClinicalTrials.gov ID
- NCT01947439
- Acronym / sponsor ID
- BATTLE IN MULTI
- Conditions
- Multivessel Coronary Artery Disease
- Keywords
- multivessel stenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 932 participants (actual)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jun 2021 (actual)
- Study completion
- Jun 2021 (actual)
- First posted
- 20 Sep 2013 (estimated)
- 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 risk of restenosis in the treatment of coronary artery disease has significantly lessened thanks to the introduction of Drug eluting stent.
Yet, debates on the efficacy and safety of stents in complex lesions or patients have been circulated.
Recently, PCI in multiple lesions is universally performed with the development of effective stents in various kinds in the clinics.
However, a randomized study is rare for multi-vessel coronary artery disease in real procedural environments.
The primary purpose of this study is to evaluate the clinical progress of biolimus A9-eluting stent and zotarolimus-eluting stent in multi-vessel coronary artery disease.
Detailed description
The patients who need multi-vessel stenting with multi-vessel coronary artery disease will be enrolled.Each randomization of the enrolled subjects will be done 1:1 (biolimus A9-eluting stent : zotarolimus-eluting stent). Randomization will be stratified by two factors: Diabetes mellitus and Acute coronary syndrome.Clinical follow-up will occur at the following time points; 1 month, 1 year and 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biolimus A9 eluting stent | Experimental | Procedure: Percutaneous Coronary Interventionbiolimus A9 stent( Biomatrix or Biomatrix Flex) will be placed in under Percutaneous Coronary Intervention. |
| Zotarolimus-eluting stent | Active comparator | Procedure: Percutaneous Coronary Interventionzotarolimus eluting stent (Resolute Integrity) will be placed in under Percutaneous Coronary Intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients who need multi-vessel stenting with multi-vessel disease
- patients with signed informed consent
Key exclusion criteria (6 listed)
- known contraindication to any of the following medications: Aspirin,clopidogrel, heparin, contrast agent, Biolimus or Zotarolimus group
- Cardiogenic shock
- Pregnant women or women with potential childbearing
- End-stage diseases with life expectancy shorter than 2 years
- patients with other Drug eluting stents implanted
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 |
|---|---|---|
| Percutaneous Coronary InterventionAlso: -Resolute Integrity, -Biomatrix, -Biomatrix FlexPercutaneous Transluminal coronary angioplasty and Intervention will be performed in both of randomized groups of biolimus A9 eluting stent and zotarolimus eluting stent | Procedure or surgery | Biolimus A9 eluting stent, Zotarolimus-eluting stent |
Primary outcome
2-year composite end points
Time frame: up to 2 years
All cause death, non fatal myocardial infarction, any revascularization
8 secondary outcomes
All cause death
Time frame: up to 2 years
non-cardiac death
Time frame: up to 2 years
cardiac death
Time frame: up to 2 years
non fatal myocardial infarction
Time frame: up to 2 years
Any revascularization
Time frame: up to 2 years
Target lesion revascularization
Time frame: up to 2 years
Target vessel revascularization
Time frame: up to 2 years
stent thrombosis
Time frame: up to 2 years
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 1 Sep 2021.
- Derived from this study: PubMed 40097279Lee CH, Lee HJ, Chung TW, Lee S, Hwang J, Kim IC, Cho YK, Yoon HJ, Hur SH, Kim JY, Kim YS, Jang WS, Lee JH, Kim W, Lee JB, Hong YJ, Heo JH, Lee BR, Doh JH, Shin ES, Koo BK, Nam CW. Comparison of Thick Biolimus A9-Eluting Stent and Thin Zotarolimus-Eluting Stent in Multi-Vessel Percutaneous Coronary Intervention. Korean Circ J. 2025 May;55(5):396-407. doi: 10.4070/kcj.2024.0101. Epub 2025 Feb 17.
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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.
Chang-Wook Nam, Postdoctoral principal investigator
Keimyung University Dongsan Medical Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Coronary Intervention in people with Multivessel Coronary Artery Disease, run by Keimyung University Dongsan Medical Center at 9 sites 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 2 inclusion and 6 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 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
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?
2-year composite end points (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01947439, which also lists 1 linked publication.
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 1 Sep 2021.