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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cypher
Endeavor Resolute
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

  • Stcarollo Hospital
  • Konyang University Hospital
  • Soon Chun Hyang University Hospital Bucheon
  • Inje University Ilsan Paik Hospital
  • Wonju Christian Hospital
  • Yeungnam University Medical Center
  • Busan Paik Hospital
  • Dong-A University Medical Center
  • Soonchunhyang University Cheonan Hospital
  • Gangwon National University Hospital
  • Asan Medical Center
  • Kyung Hee University Medical Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Cypher

Endeavor Resolute

Arm Description

Sirolimus-eluting stent

Zotarolimus-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 (normal hospitalization is from 3 -4 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 6, 2012
Sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea, Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT01186094
Brief Title
Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-IV: (LONG-DES-IV)
Acronym
LONG-DES-IV
Official Title
Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-IV: Sirolimus vs. Zotarolimus-eluting Stent
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

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

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 (Cypher) versus zotarolimus-eluting stent (Endeavor Resolute) 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 IV trial inclusion and exclusion criteria will be randomized 1:1 to a) CYPHER and b) ENDEAVOR RESOLUTE 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
502 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cypher
Arm Type
Active Comparator
Arm Description
Sirolimus-eluting stent
Arm Title
Endeavor Resolute
Arm Type
Active Comparator
Arm Description
Zotarolimus-eluting Stent
Intervention Type
Device
Intervention Name(s)
Cypher
Other Intervention Name(s)
Sirolimus-eluting stent
Intervention Description
Sirolimus-eluting stent
Intervention Type
Device
Intervention Name(s)
Endeavor Resolute
Other Intervention Name(s)
Zotarolimus-eluting Stent
Intervention Description
Zotarolimus-eluting Stent
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
1 year
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
12 months
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 (normal hospitalization is from 3 -4 days.)
Time Frame
at 3 days in average
Title
All death
Time Frame
one month
Title
All death
Time Frame
9 months
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
Stcarollo Hospital
City
Suncheon
State/Province
Cheon-nam
Country
Korea, Republic of
Facility Name
Konyang University Hospital
City
Daejeon
State/Province
Chungnam
Country
Korea, Republic of
Facility Name
Soon Chun Hyang University Hospital Bucheon
City
Bucheon
State/Province
Gyeong-gi
Country
Korea, Republic of
Facility Name
Inje University Ilsan Paik Hospital
City
Ilsan
State/Province
Gyeong-gi
Country
Korea, Republic of
Facility Name
Wonju Christian Hospital
City
Wonju
State/Province
Kangwon
Country
Korea, Republic of
Facility Name
Yeungnam University Medical Center
City
Daegu
State/Province
Kyung-book
Country
Korea, Republic of
Facility Name
Busan Paik Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Dong-A University Medical Center
City
Busan
Country
Korea, Republic of
Facility Name
Soonchunhyang University Cheonan Hospital
City
Cheonan
Country
Korea, Republic of
Facility Name
Gangwon National University Hospital
City
Chuncheon
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Kyung Hee University Medical Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
23048051
Citation
Ahn JM, Park DW, Kim YH, Song H, Cho YR, Kim WJ, Lee JY, Kang SJ, Lee SW, Lee CW, Park SW, Yun SC, Han S, Lee SY, Lee BK, Cho JH, Yang TH, Lee NH, Yang JY, Park JS, Shin WY, Kim MH, Bae JH, Kim MK, Yoon J, Park SJ. Comparison of resolute zotarolimus-eluting stents and sirolimus-eluting stents in patients with de novo long coronary artery lesions: a randomized LONG-DES IV trial. Circ Cardiovasc Interv. 2012 Oct;5(5):633-40. doi: 10.1161/CIRCINTERVENTIONS.111.965673. Epub 2012 Oct 9.
Results Reference
derived

Learn more about this trial

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

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