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Completed

NCT Number: NCT01186094

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Stcarollo Hospital, Suncheon, Cheon-nam, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

Cypher

Device

Sirolimus-eluting stent

Other names: Sirolimus-eluting stent

Endeavor Resolute

Device

Zotarolimus-eluting Stent

Other names: Zotarolimus-eluting Stent

Primary outcomes

  1. In-segment late luminal loss

    Time frame: 9 month follow-up

Secondary outcomes

  1. All Death

    Time frame: 1 year

  2. Cardiac death

    Time frame: 1 year

  3. Myocardial infarction (MI)

    Time frame: 1 year

  4. Composite of death or MI

    Time frame: 1 year

  5. Composite of cardiac death or MI

    Time frame: 1 year

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

    Time frame: 1 year

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

    Time frame: 1 year

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

    Time frame: 12 months

  9. Stent thrombosis (ARC criteria)

    Time frame: 1 year

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

    Time frame: at 9 month angiographic follow-up

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

    Time frame: at 9 month angiographic follow-up

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

    Time frame: at 9 month angiographic follow-up

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

    Time frame: at 9 month angiographic follow-up

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

    Time frame: 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.

    Time frame: at 3 days in average

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

  16. All death

    Time frame: one month

  17. All death

    Time frame: 9 months

  18. Cardiac death

    Time frame: one month

  19. Cardiac death

    Time frame: 9 months

  20. Myocardial infarction (MI)

    Time frame: one month

  21. Myocardial infarction (MI)

    Time frame: 9 months

  22. Composite of death or MI

    Time frame: one month

  23. Composite of death or MI

    Time frame: 9 months

  24. Composite of cardiac death or MI

    Time frame: one month

  25. Composite of cardiac death or MI

    Time frame: 9 months

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

    Time frame: one month

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

    Time frame: 9 months

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

    Time frame: one month

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

    Time frame: 9 months

  30. Stent thrombosis (ARC criteria)

    Time frame: one month

  31. Stent thrombosis (ARC criteria)

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

Seung-Jung Park

Other

Collaborators

  • CardioVascular Research Foundation, Korea
  • Medtronic

Registry information

Official study title

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

Acronym: LONG-DES-IV

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Aug 23, 2010
Registry last updated
Aug 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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