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Coronary Artery DiseasePhase 4LONG-DES-VNCT01186120

Everolimus-eluting(PROMUS-ELEMENT) vs. Biolimus A9-Eluting(NOBORI) Stents for Long-Coronary Lesions

A Phase 4 study testing Biolimus A9-eluting stent and Everolimus-eluting stent in people with Coronary Artery Disease, run by Seung-Jung Park at 11 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized study is a multi-center, randomized, study to compare the efficacy of biolimus A9-eluting stent (Nobori) vs. everolimus-eluting stent (Promus Element) for long coronary lesions. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Biolimus A9-eluting stent and Everolimus-eluting stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
11 sitesSouth Korea
Study dates
Aug 2010to Aug 2013
Phase
Phase 4
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

  • The patient must be at least 18 years of age.
  • Significant native coronary artery stenosis (>50% by visual estimate) with lesion length of more than 25mm, which requiring single or multiple long stent placement (>=28mm)
  • Patients with silent ischemia, stable or unstable angina pectoris, ad Non-ST-elevation myocardial infarction
  • The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Who cannot join

  • Any contraindication to any of the following medications: aspirin, heparin, clopidogrel, stainless steel, contrast agents, sirolimus, or everolimus.
  • An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 6 months post enrollment.
  • Acute ST-segment-elevation MI or cardiogenic shock
  • Terminal illness with life expectancy <1 year
  • Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
  • In-stent restenosis at target vessel (either bare metal stent or drug-eluting stent segment, non-target vessel ISR is permitted) Patients with EF<30%.
  • Serum creatinine level >=3.0mg/dL or dependence on dialysis.
  • Patients with left main stem stenosis (>50% by visual estimate).

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

South Korea11 sites

  • Soonchunhyang University Hospital, Buchen

    Bucheon-si

  • Soonchunhyang University Cheonan Hospital

    Cheonan

  • Kangwon National University Hospital

    Chooncheon

  • Daegu Catholic University Medical Center

    Daegu

  • Keimyung University Dongsan Medical Center

    Daegu

  • Kyungpook National University Hospital

    Daegu

  • NHIC Ilsan Hospital

    Ilsan

  • Dong-A University Medical Center

    Pusan

  • Inje University Pusan Paik Hospital

    Pusan

  • Asan Medical Center

    Seoul

  • Catholic University, Kangnam St. Mary's Hospital

    Seoul

Other trials in South Korea

About this study

Official title: Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-V:Everolimus-eluting(PROMUS-ELEMENT) vs. Biolimus A9-Eluting(NOBORI) Stents

This randomized study is a multi-center, randomized, study to compare the efficacy of biolimus A9-eluting stent (Nobori) vs. everolimus-eluting stent (Promus Element) for long coronary lesions.

Read the detailed description

Following angiography, patients with significant diameter stenosis >50% and lesion length(> 25mm) requiring single or multiple long-stent placement(total stent length 28mm) by visual estimation and eligible for LONG-DES V trial inclusion and exclusion criteria will be randomized 1:1 to a) NOBORI and b) PROMUS-ELEMENT stent by the stratified randomization method.

Being tested
Biolimus A9-eluting stent, Everolimus-eluting stent
Keywords
coronary disease, stent
Medical subject headings
Coronary Artery Disease, Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biolimus A9-eluting stentDevice

    Also called NOBORI stent

    drug-eluting stent

  • Everolimus-eluting stentDevice

    Also called PROMUS ELEMENT stent

    drug-eluting stent

Study groups in NCT01186120
Study groupRoleWhat they receive
Biolimus A9-eluting stentExperimentalNOBORI stent
Receives: Device: Biolimus A9-eluting stent
Everolimus-eluting stentActive comparatorPROMUS ELEMENTE stent
Receives: Device: Everolimus-eluting stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. In-segment late luminal loss

    Measured: 9 month angiographic follow-up

Secondary outcomes (26)

  1. Death (all-cause and cardiac)

    Measured: 1 year

  2. Myocardial infarction

    Measured: 1 year

  3. stent thrombosis(ARC criteria)

    Measured: 1 year

  4. target-lesion revascularization

    Measured: 1 year

  5. target-vessel revascularization

    Measured: 1 year

  6. Procedural success

    Measured: at 1 day

  7. Death (all-cause and cardiac)

    Measured: one month

  8. Death (all-cause and cardiac)

    Measured: 9 months

  9. Myocardial infarction

    Measured: one month

  10. Myocardial infarction

    Measured: 9 months

  11. Composite of death or MI

    Measured: one month

  12. Composite of death or MI

    Measured: 9 months

  13. Composite of death or MI

    Measured: 1 year

  14. Composite of cardiac death or MI

    Measured: one month

  15. Composite of cardiac death or MI

    Measured: 9 months

  16. Composite of cardiac death or MI

    Measured: 1 year

  17. target-lesion revascularization

    Measured: one month

  18. target-lesion revascularization

    Measured: 9 months

  19. target-vessel revascularization

    Measured: one month

  20. target-vessel revascularization

    Measured: 9 months

  21. stent thrombosis(ARC criteria)

    Measured: one month

  22. stent thrombosis(ARC criteria)

    Measured: 9 months

  23. In-stent late loss

    Measured: 9 month angiographic follow-up

  24. 8. Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization)

    Measured: 12 months

  25. In-stent and in-segment restenosis

    Measured: 9 month angiographic follow-up

  26. Angiographic pattern of restenosis

    Measured: 9 month angiographic follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionMay 2013
  4. Study completionAug 2013

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01186120
Sponsor's protocol ID
2010-0036
Acronym
LONG-DES-V
Status last verified
Nov 2013
First submitted
18 Aug 2010
Last updated
6 Nov 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Kang DY, Jang JS, Chang M, Lee CH, Lee PH, Ahn JM, Lee SW, Kim YH, Park SW, Park DW, Park SJ; LONG-DES Investigators. Comparison of Different Types of Drug-Eluting Stents for De Novo Long Coronary Artery Lesions. JACC Asia. 2022 May 24;2(4):446-456. doi: 10.1016/j.jacasi.2022.02.009. eCollection 2022 Aug.

    PubMed 36339368

  • Lee JY, Park DW, Kim YH, Ahn JM, Kim WJ, Kang SJ, Lee SW, Lee CW, Park SW, Yun SC, Yang TH, Lee BK, Lee NH, Yang JY, Shin WY, Park HS, Kim KS, Hur SH, Lee SY, Park JS, Choi YS, Lee SU, Her SH, Park SJ. Comparison of biolimus A9-eluting (Nobori) and everolimus-eluting (Promus Element) stents in patients with de novo native long coronary artery lesions: a randomized Long Drug-Eluting Stent V trial. Circ Cardiovasc Interv. 2014 Jun;7(3):322-9. doi: 10.1161/CIRCINTERVENTIONS.113.000841. Epub 2014 May 13.

    PubMed 24823426

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Biolimus A9-eluting stent and Everolimus-eluting stent in people with Coronary Artery Disease, run by Seung-Jung Park at 11 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 4 inclusion and 8 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 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

In-segment late luminal loss (time frame: 9 month angiographic follow-up). 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 NCT01186120, which also lists 2 linked publications.

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 6 Nov 2013.

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