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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Biolimus A9-eluting stent
Everolimus-eluting stent
Sponsored by
Seung-Jung Park
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring coronary disease, stent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Soonchunhyang University Hospital, Buchen
  • Soonchunhyang University Cheonan Hospital
  • Kangwon National University Hospital
  • Daegu Catholic University Medical Center
  • Keimyung University Dongsan Medical Center
  • Kyungpook National University Hospital
  • NHIC Ilsan Hospital
  • Dong-A University Medical Center
  • Inje University Pusan Paik Hospital
  • Asan Medical Center
  • Catholic University, Kangnam St. Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Biolimus A9-eluting stent

Everolimus-eluting stent

Arm Description

NOBORI stent

PROMUS ELEMENTE stent

Outcomes

Primary Outcome Measures

In-segment late luminal loss

Secondary Outcome Measures

Death (all-cause and cardiac)
Myocardial infarction
stent thrombosis(ARC criteria)
target-lesion revascularization
target-vessel revascularization
Procedural success
Death (all-cause and cardiac)
Death (all-cause and cardiac)
Myocardial infarction
Myocardial infarction
Composite of death or MI
Composite of death or MI
Composite of death or MI
Composite of cardiac death or MI
Composite of cardiac death or MI
Composite of cardiac death or MI
target-lesion revascularization
target-lesion revascularization
target-vessel revascularization
target-vessel revascularization
stent thrombosis(ARC criteria)
stent thrombosis(ARC criteria)
In-stent late loss
8. Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization)
In-stent and in-segment restenosis
Angiographic pattern of restenosis

Full Information

First Posted
August 18, 2010
Last Updated
November 5, 2013
Sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT01186120
Brief Title
Everolimus-eluting(PROMUS-ELEMENT) vs. Biolimus A9-Eluting(NOBORI) Stents for Long-Coronary Lesions
Acronym
LONG-DES-V
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 Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
coronary disease, stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biolimus A9-eluting stent
Arm Type
Experimental
Arm Description
NOBORI stent
Arm Title
Everolimus-eluting stent
Arm Type
Active Comparator
Arm Description
PROMUS ELEMENTE stent
Intervention Type
Device
Intervention Name(s)
Biolimus A9-eluting stent
Other Intervention Name(s)
NOBORI stent
Intervention Description
drug-eluting stent
Intervention Type
Device
Intervention Name(s)
Everolimus-eluting stent
Other Intervention Name(s)
PROMUS ELEMENT stent
Intervention Description
drug-eluting stent
Primary Outcome Measure Information:
Title
In-segment late luminal loss
Time Frame
9 month angiographic follow-up
Secondary Outcome Measure Information:
Title
Death (all-cause and cardiac)
Time Frame
1 year
Title
Myocardial infarction
Time Frame
1 year
Title
stent thrombosis(ARC criteria)
Time Frame
1 year
Title
target-lesion revascularization
Time Frame
1 year
Title
target-vessel revascularization
Time Frame
1 year
Title
Procedural success
Time Frame
at 1 day
Title
Death (all-cause and cardiac)
Time Frame
one month
Title
Death (all-cause and cardiac)
Time Frame
9 months
Title
Myocardial infarction
Time Frame
one month
Title
Myocardial infarction
Time Frame
9 months
Title
Composite of death or MI
Time Frame
one month
Title
Composite of death or MI
Time Frame
9 months
Title
Composite of death or MI
Time Frame
1 year
Title
Composite of cardiac death or MI
Time Frame
one month
Title
Composite of cardiac death or MI
Time Frame
9 months
Title
Composite of cardiac death or MI
Time Frame
1 year
Title
target-lesion revascularization
Time Frame
one month
Title
target-lesion revascularization
Time Frame
9 months
Title
target-vessel revascularization
Time Frame
one month
Title
target-vessel revascularization
Time Frame
9 months
Title
stent thrombosis(ARC criteria)
Time Frame
one month
Title
stent thrombosis(ARC criteria)
Time Frame
9 months
Title
In-stent late loss
Time Frame
9 month angiographic follow-up
Title
8. Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization)
Time Frame
12 months
Title
In-stent and in-segment restenosis
Time Frame
9 month angiographic follow-up
Title
Angiographic pattern of restenosis
Time Frame
9 month angiographic follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung-Jung Park, MD.,PhD.
Organizational Affiliation
Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soonchunhyang University Hospital, Buchen
City
Bucheon
Country
Korea, Republic of
Facility Name
Soonchunhyang University Cheonan Hospital
City
Cheonan
Country
Korea, Republic of
Facility Name
Kangwon National University Hospital
City
Chooncheon
Country
Korea, Republic of
Facility Name
Daegu Catholic University Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
NHIC Ilsan Hospital
City
Ilsan
Country
Korea, Republic of
Facility Name
Dong-A University Medical Center
City
Pusan
Country
Korea, Republic of
Facility Name
Inje University Pusan Paik Hospital
City
Pusan
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Catholic University, Kangnam St. Mary's Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
36339368
Citation
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.
Results Reference
derived
PubMed Identifier
24823426
Citation
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.
Results Reference
derived

Learn more about this trial

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

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