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Coronary Artery DiseasePhase 4LONG-DES-IVNCT01186094

Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-IV: (LONG-DES-IV)

A Phase 4 study testing Cypher and Endeavor Resolute in people with Coronary Artery Disease, run by Seung-Jung Park at 12 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 sirolimus (Cypher) versus zotarolimus-eluting stent (Endeavor Resolute) implantation 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?
Cypher and Endeavor Resolute
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
502 participants
Where
12 sitesSouth Korea
Study dates
May 2009to Jun 2011
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)
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  • 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

12 sites in 1 country.

12 sites in 1 country

South Korea12 sites

  • Soon Chun Hyang University Hospital Bucheon

    Bucheon-si, Gyeonggi-do

  • Busan Paik Hospital

    Busan

  • Dong-A University Medical Center

    Busan

  • Soonchunhyang University Cheonan Hospital

    Cheonan

  • Gangwon National University Hospital

    Chuncheon

  • Yeungnam University Medical Center

    Daegu, Kyung-book

  • Konyang University Hospital

    Daejeon, Chungcheongnam-do

  • Inje University Ilsan Paik Hospital

    Ilsan, Gyeonggi-do

  • Asan Medical Center

    Seoul

  • Kyung Hee University Medical Hospital

    Seoul

  • Stcarollo Hospital

    Suncheon, Cheon-nam

  • Wonju Christian Hospital

    Wŏnju, Gangwon-do

Other trials in South Korea

About this study

Official title: Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-IV: Sirolimus vs. Zotarolimus-eluting Stent

This randomized study is a multi-center, randomized, study to compare the efficacy of sirolimus (Cypher) versus zotarolimus-eluting stent (Endeavor Resolute) implantation 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 IV trial inclusion and exclusion criteria will be randomized 1:1 to a) CYPHER and b) ENDEAVOR RESOLUTE stent by the stratified randomization method.

Being tested
Cypher, Endeavor Resolute
Keywords
Coronary Artery Disease, 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.

  • CypherDevice

    Also called Sirolimus-eluting stent

    Sirolimus-eluting stent

  • Endeavor ResoluteDevice

    Also called Zotarolimus-eluting Stent

    Zotarolimus-eluting Stent

Study groups in NCT01186094
Study groupRoleWhat they receive
CypherActive comparatorSirolimus-eluting stent
Receives: Device: Cypher
Endeavor ResoluteActive comparatorZotarolimus-eluting Stent
Receives: Device: Endeavor Resolute

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 follow-up

Secondary outcomes (31)

  1. All Death

    Measured: 1 year

  2. Cardiac death

    Measured: 1 year

  3. Myocardial infarction (MI)

    Measured: 1 year

  4. Composite of death or MI

    Measured: 1 year

  5. Composite of cardiac death or MI

    Measured: 1 year

  6. Target vessel revascularization (ischemia-driven and clinically-driven)

    Measured: 1 year

  7. Target lesion revascularization (ischemia-driven and clinically-driven)

    Measured: 1 year

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

    Measured: 12 months

  9. Stent thrombosis (ARC criteria)

    Measured: 1 year

  10. In-stent late loss at 9 month angiographic follow-up

    Measured: at 9 month angiographic follow-up

  11. In-stent and in-segment restenosis at 9 month angiographic follow-up

    Measured: at 9 month angiographic follow-up

  12. Angiographic pattern of restenosis at 9 month angiographic follow-up

    Measured: at 9 month angiographic follow-up

  13. Volume of intimal hyperplasia at 9 month IVUS follow-up (sub-study)

    Measured: at 9 month angiographic follow-up

  14. Incidence of late stent malapposition at 9 month IVUS follow-up (sub-study)

    Measured: at 9 month angiographic follow-up

  15. Procedural success defined as achievement of a final diameter stenosis of <30% by QCA using any percutaneous method, without the occurrence of death, Q wave MI, or repeat revascularization of the target lesion during the hospital stay.

    At discharge from the index hospitalization (normal hospitalization is from 3 -4 days.)

    Measured: at 3 days in average

  16. All death

    Measured: one month

  17. All death

    Measured: 9 months

  18. Cardiac death

    Measured: one month

  19. Cardiac death

    Measured: 9 months

  20. Myocardial infarction (MI)

    Measured: one month

  21. Myocardial infarction (MI)

    Measured: 9 months

  22. Composite of death or MI

    Measured: one month

  23. Composite of death or MI

    Measured: 9 months

  24. Composite of cardiac death or MI

    Measured: one month

  25. Composite of cardiac death or MI

    Measured: 9 months

  26. Target vessel revascularization (ischemia-driven and clinically-driven)

    Measured: one month

  27. Target vessel revascularization (ischemia-driven and clinically-driven)

    Measured: 9 months

  28. Target lesion revascularization (ischemia-driven and clinically-driven)

    Measured: one month

  29. Target lesion revascularization (ischemia-driven and clinically-driven)

    Measured: 9 months

  30. Stent thrombosis (ARC criteria)

    Measured: one month

  31. Stent thrombosis (ARC criteria)

    Measured: 9 months

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 startMay 2009
  3. Primary completionApr 2011
  4. Study completionJun 2011

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
502 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01186094
Sponsor's protocol ID
2008-0086
Acronym
LONG-DES-IV
Status last verified
Aug 2012
First submitted
18 Oct 2009
Last updated
8 Aug 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Ahn JM, Park DW, Kim YH, Song H, Cho YR, Kim WJ, Lee JY, Kang SJ, Lee SW, Lee CW, Park SW, Yun SC, Han S, Lee SY, Lee BK, Cho JH, Yang TH, Lee NH, Yang JY, Park JS, Shin WY, Kim MH, Bae JH, Kim MK, Yoon J, Park SJ. Comparison of resolute zotarolimus-eluting stents and sirolimus-eluting stents in patients with de novo long coronary artery lesions: a randomized LONG-DES IV trial. Circ Cardiovasc Interv. 2012 Oct;5(5):633-40. doi: 10.1161/CIRCINTERVENTIONS.111.965673. Epub 2012 Oct 9.

    PubMed 23048051

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Cypher and Endeavor Resolute in people with Coronary Artery Disease, run by Seung-Jung Park at 12 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 9 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 8 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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 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 NCT01186094, 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 8 Aug 2012.

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