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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cypher
Xience V
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 Artery 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

  • Sam Anyang Hospital
  • Soonchunhyang University Bucheon Hospital
  • Busan Paik Hospital
  • St.Mary's Catholic Medical Center
  • Soonchunhyang University Cheonan Hospital
  • St.Mary's Catholic Medical Center
  • Gangwon National University Hospital
  • Chungnam National University Hospital
  • Asan Medical Center
  • Gwangju Christian Hospital
  • Dongguk University Hospital
  • St.Mary's Catholic Medical Center
  • Jeju Hanla Hospital
  • Gyeongsang Uniservity Hospital
  • Asan Medical Center
  • Hangang Sacred Heart Hospital
  • Seoul Veterans Hospital
  • St.Mary's Catholic Medical Center
  • Ajou University Hospital
  • Ulsan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cypher

Xience V

Arm Description

Sirolimus-eluting stent

Everolimus-eluting stent

Outcomes

Primary Outcome Measures

In-segment late luminal loss

Secondary Outcome Measures

All Death
Cardiac death
Myocardial infarction (MI)
Composite of death or MI
Composite of cardiac death or MI
Target vessel revascularization (ischemia-driven and clinically-driven)
Target lesion revascularization (ischemia-driven and clinically-driven)
Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization)
Stent thrombosis (ARC criteria)
In-stent late loss at 9 month angiographic follow-up
In-stent and in-segment restenosis at 9 month angiographic follow-up
Angiographic pattern of restenosis at 9 month angiographic follow-up
Volume of intimal hyperplasia at 9 month IVUS follow-up (sub-study)
Incidence of late stent malapposition at 9 month IVUS follow-up (sub-study)
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.
At discharge from the index hospitalization, participants will be followed for the duration of hospital stay, an expected average of 3 days.
All Death
All Death
Cardiac death
Cardiac death
Myocardial infarction (MI)
Myocardial infarction (MI)
Composite of death or MI
Composite of death or MI
Composite of cardiac death or MI
Composite of cardiac death or MI
Target vessel revascularization (ischemia-driven and clinically-driven)
Target vessel revascularization (ischemia-driven and clinically-driven)
Target lesion revascularization (ischemia-driven and clinically-driven)
Target lesion revascularization (ischemia-driven and clinically-driven)
Stent thrombosis (ARC criteria)
Stent thrombosis (ARC criteria)

Full Information

First Posted
October 18, 2009
Last Updated
August 7, 2012
Sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT01078038
Brief Title
Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III (LONG-DES-III)
Acronym
LONG-DES-III
Official Title
Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III: Sirolimus vs. Everolimus-eluting Stent
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
August 2010 (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 sirolimus versus everolimus-eluting stent implantation 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 III trial inclusion and exclusion criteria will be randomized 1:1 to a) sirolimus-eluting and b) everolimus-eluting 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 Artery Disease, Stent

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Cypher
Arm Type
Active Comparator
Arm Description
Sirolimus-eluting stent
Arm Title
Xience V
Arm Type
Active Comparator
Arm Description
Everolimus-eluting stent
Intervention Type
Device
Intervention Name(s)
Cypher
Other Intervention Name(s)
Sirolimus-eluting stent
Intervention Description
Sirolimus-eluting stent implantation
Intervention Type
Device
Intervention Name(s)
Xience V
Other Intervention Name(s)
Everolimus-eluting Stent
Intervention Description
Everolimus-eluting Stent implantation
Primary Outcome Measure Information:
Title
In-segment late luminal loss
Time Frame
9 month follow-up
Secondary Outcome Measure Information:
Title
All Death
Time Frame
one month
Title
Cardiac death
Time Frame
1 year
Title
Myocardial infarction (MI)
Time Frame
1 year
Title
Composite of death or MI
Time Frame
1 year
Title
Composite of cardiac death or MI
Time Frame
1 year
Title
Target vessel revascularization (ischemia-driven and clinically-driven)
Time Frame
1 year
Title
Target lesion revascularization (ischemia-driven and clinically-driven)
Time Frame
1 year
Title
Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization)
Time Frame
1 year
Title
Stent thrombosis (ARC criteria)
Time Frame
1 year
Title
In-stent late loss at 9 month angiographic follow-up
Time Frame
at 9 month angiographic follow-up
Title
In-stent and in-segment restenosis at 9 month angiographic follow-up
Time Frame
at 9 month angiographic follow-up
Title
Angiographic pattern of restenosis at 9 month angiographic follow-up
Time Frame
at 9 month angiographic follow-up
Title
Volume of intimal hyperplasia at 9 month IVUS follow-up (sub-study)
Time Frame
at 9 month angiographic follow-up
Title
Incidence of late stent malapposition at 9 month IVUS follow-up (sub-study)
Time Frame
at 9 month angiographic follow-up
Title
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.
Description
At discharge from the index hospitalization, participants will be followed for the duration of hospital stay, an expected average of 3 days.
Time Frame
3 days in average
Title
All Death
Time Frame
9 months
Title
All Death
Time Frame
one year
Title
Cardiac death
Time Frame
one month
Title
Cardiac death
Time Frame
9 months
Title
Myocardial infarction (MI)
Time Frame
one month
Title
Myocardial infarction (MI)
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 cardiac death or MI
Time Frame
one month
Title
Composite of cardiac death or MI
Time Frame
9 months
Title
Target vessel revascularization (ischemia-driven and clinically-driven)
Time Frame
one month
Title
Target vessel revascularization (ischemia-driven and clinically-driven)
Time Frame
9 months
Title
Target lesion revascularization (ischemia-driven and clinically-driven)
Time Frame
one month
Title
Target lesion revascularization (ischemia-driven and clinically-driven)
Time Frame
9 months
Title
Stent thrombosis (ARC criteria)
Time Frame
one month
Title
Stent thrombosis (ARC criteria)
Time Frame
9 months

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
Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sam Anyang Hospital
City
Anyang
Country
Korea, Republic of
Facility Name
Soonchunhyang University Bucheon Hospital
City
Bucheon
Country
Korea, Republic of
Facility Name
Busan Paik Hospital
City
Busan
Country
Korea, Republic of
Facility Name
St.Mary's Catholic Medical Center
City
Busan
Country
Korea, Republic of
Facility Name
Soonchunhyang University Cheonan Hospital
City
Cheonan
Country
Korea, Republic of
Facility Name
St.Mary's Catholic Medical Center
City
Cheongju
Country
Korea, Republic of
Facility Name
Gangwon National University Hospital
City
Chuncheon
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
GangNeung
Country
Korea, Republic of
Facility Name
Gwangju Christian Hospital
City
Gwangju
Country
Korea, Republic of
Facility Name
Dongguk University Hospital
City
Gyongju
Country
Korea, Republic of
Facility Name
St.Mary's Catholic Medical Center
City
Inchon
Country
Korea, Republic of
Facility Name
Jeju Hanla Hospital
City
Jeju
Country
Korea, Republic of
Facility Name
Gyeongsang Uniservity Hospital
City
Jinju
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Hangang Sacred Heart Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Veterans Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
St.Mary's Catholic Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon
Country
Korea, Republic of
Facility Name
Ulsan University Hospital
City
Ulsan
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
22017935
Citation
Park DW, Kim YH, Song HG, Ahn JM, Kim WJ, Lee JY, Kang SJ, Lee SW, Lee CW, Park SW, Yun SC, Seung KB, Yang TH, Lee SG, Lee JH, Seong IW, Cheong SS, Lee BK, Lee NH, Lee SW, Lee SW, Lee K, Kim HS, Jeon DS, Kim MK, Nah DY, Tahk SJ, Park SJ. Comparison of everolimus- and sirolimus-eluting stents in patients with long coronary artery lesions: a randomized LONG-DES-III (Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III) Trial. JACC Cardiovasc Interv. 2011 Oct;4(10):1096-103. doi: 10.1016/j.jcin.2011.05.024.
Results Reference
derived

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

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