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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Biolimus A9-eluting stent; Device: Everolimus-eluting stent

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
• Enrollment (Actual): 500
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Bucheon, Korea, Republic of
    • Soonchunhyang University Hospital, Buchen
  • Cheonan, Korea, Republic of
    • Soonchunhyang University Cheonan Hospital
  • Chooncheon, Korea, Republic of
    • Kangwon National University Hospital
  • Daegu, 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
  • Ilsan, Korea, Republic of
    • NHIC Ilsan Hospital
  • Pusan, Korea, Republic of
    • Inje University Pusan Paik Hospital
  • Pusan, Korea, Republic of
    • Dong-A University Medical Center
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Catholic University, Kangnam St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biolimus A9-eluting stent; NOBORI stent	Device: Biolimus A9-eluting stent; drug-eluting stent; Other Names: NOBORI stent
Active Comparator: Everolimus-eluting stent; PROMUS ELEMENTE stent	Device: Everolimus-eluting stent; drug-eluting stent; Other Names: PROMUS ELEMENT stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
In-segment late luminal loss	9 month angiographic follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
Death (all-cause and cardiac)	1 year
Myocardial infarction	1 year
stent thrombosis(ARC criteria)	1 year
target-lesion revascularization	1 year
target-vessel revascularization	1 year
Procedural success	at 1 day
Death (all-cause and cardiac)	one month
Death (all-cause and cardiac)	9 months
Myocardial infarction	one month
Myocardial infarction	9 months
Composite of death or MI	one month
Composite of death or MI	9 months
Composite of death or MI	1 year
Composite of cardiac death or MI	one month
Composite of cardiac death or MI	9 months
Composite of cardiac death or MI	1 year
target-lesion revascularization	one month
target-lesion revascularization	9 months
target-vessel revascularization	one month
target-vessel revascularization	9 months
stent thrombosis(ARC criteria)	one month
stent thrombosis(ARC criteria)	9 months
In-stent late loss	9 month angiographic follow-up
8. Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization)	12 months
In-stent and in-segment restenosis	9 month angiographic follow-up
Angiographic pattern of restenosis	9 month angiographic follow-up

Collaborators and Investigators

• Sponsor: Seung-Jung Park
• Collaborators: CardioVascular Research Foundation, Korea
• Investigators: Principal Investigator: Seung-Jung Park, MD.,PhD., Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: August 18, 2010
• First Submitted That Met QC Criteria: August 20, 2010
• First Posted (Estimate): August 23, 2010

Study Record Updates

• Last Update Posted (Estimate): November 6, 2013
• Last Update Submitted That Met QC Criteria: November 5, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: coronary disease; stent
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Everolimus; Umirolimus
• Other Study ID Numbers: 2010-0036