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Completed

NCT Number: NCT01186120

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Soonchunhyang University Hospital, Buchen, Bucheon-si, South Korea

Loading trial locations.

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 V trial inclusion and exclusion criteria will be randomized 1:1 to a) NOBORI and b) PROMUS-ELEMENT 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

Biolimus A9-eluting stent

Device

drug-eluting stent

Other names: NOBORI stent

everolimus-eluting stent

Device

drug-eluting stent

Other names: PROMUS ELEMENT stent

Primary outcomes

  1. In-segment late luminal loss

    Time frame: 9 month angiographic follow-up

Secondary outcomes

  1. Death (all-cause and cardiac)

    Time frame: 1 year

  2. Myocardial infarction

    Time frame: 1 year

  3. stent thrombosis(ARC criteria)

    Time frame: 1 year

  4. target-lesion revascularization

    Time frame: 1 year

  5. target-vessel revascularization

    Time frame: 1 year

  6. Procedural success

    Time frame: at 1 day

  7. Death (all-cause and cardiac)

    Time frame: one month

  8. Death (all-cause and cardiac)

    Time frame: 9 months

  9. Myocardial infarction

    Time frame: one month

  10. Myocardial infarction

    Time frame: 9 months

  11. Composite of death or MI

    Time frame: one month

  12. Composite of death or MI

    Time frame: 9 months

  13. Composite of death or MI

    Time frame: 1 year

  14. Composite of cardiac death or MI

    Time frame: one month

  15. Composite of cardiac death or MI

    Time frame: 9 months

  16. Composite of cardiac death or MI

    Time frame: 1 year

  17. target-lesion revascularization

    Time frame: one month

  18. target-lesion revascularization

    Time frame: 9 months

  19. target-vessel revascularization

    Time frame: one month

  20. target-vessel revascularization

    Time frame: 9 months

  21. stent thrombosis(ARC criteria)

    Time frame: one month

  22. stent thrombosis(ARC criteria)

    Time frame: 9 months

  23. In-stent late loss

    Time frame: 9 month angiographic follow-up

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

    Time frame: 12 months

  25. In-stent and in-segment restenosis

    Time frame: 9 month angiographic follow-up

  26. Angiographic pattern of restenosis

    Time frame: 9 month angiographic follow-up

Sponsors and collaborators

Lead sponsor

Seung-Jung Park

Other

Collaborators

  • CardioVascular Research Foundation, Korea

Registry information

Official study title

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

Acronym: LONG-DES-V

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Aug 23, 2010
Registry last updated
Nov 6, 2013

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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