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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01186120
Recruitment Status : Completed
First Posted : August 23, 2010
Last Update Posted : November 6, 2013
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea

Brief 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Biolimus A9-eluting stent Device: Everolimus-eluting stent Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-V:Everolimus-eluting(PROMUS-ELEMENT) vs. Biolimus A9-Eluting(NOBORI) Stents
Study Start Date : August 2010
Actual Primary Completion Date : May 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Biolimus A9-eluting stent
NOBORI stent
Device: Biolimus A9-eluting stent
drug-eluting stent
Other Name: NOBORI stent

Active Comparator: Everolimus-eluting stent
Device: Everolimus-eluting stent
drug-eluting stent
Other Name: PROMUS ELEMENT stent

Primary Outcome Measures :
  1. In-segment late luminal loss [ Time Frame: 9 month angiographic follow-up ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01186120

Korea, Republic of
Soonchunhyang University Hospital, Buchen
Bucheon, Korea, Republic of
Soonchunhyang University Cheonan Hospital
Cheonan, Korea, Republic of
Kangwon National University Hospital
Chooncheon, Korea, Republic of
Daegu Catholic University Medical Center
Daegu, Korea, Republic of
Keimyung University Dongsan Medical Center
Daegu, Korea, Republic of
Kyungpook National University Hospital
Daegu, Korea, Republic of
NHIC Ilsan Hospital
Ilsan, Korea, Republic of
Dong-A University Medical Center
Pusan, Korea, Republic of
Inje University Pusan Paik Hospital
Pusan, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Catholic University, Kangnam St. Mary's Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
Principal Investigator: Seung-Jung Park, MD.,PhD. Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Seung-Jung Park, MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine, CardioVascular Research Foundation, Korea Identifier: NCT01186120     History of Changes
Other Study ID Numbers: 2010-0036
First Posted: August 23, 2010    Key Record Dates
Last Update Posted: November 6, 2013
Last Verified: November 2013

Keywords provided by Seung-Jung Park, CardioVascular Research Foundation, Korea:
coronary disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Anti-Inflammatory Agents