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

August 7, 2012 updated by: Seung-Jung Park

Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III: Sirolimus vs. Everolimus-eluting Stent

This randomized study is a multi-center, randomized, study to compare the efficacy of sirolimus versus everolimus-eluting stent implantation for long coronary lesions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

451

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Anyang, Korea, Republic of
        • Sam Anyang Hospital
      • Bucheon, Korea, Republic of
        • Soonchunhyang University Bucheon Hospital
      • Busan, Korea, Republic of
        • Busan Paik Hospital
      • Busan, Korea, Republic of
        • St.Mary's Catholic Medical Center
      • Cheonan, Korea, Republic of
        • Soonchunhyang University Cheonan Hospital
      • Cheongju, Korea, Republic of
        • St.Mary's Catholic Medical Center
      • Chuncheon, Korea, Republic of
        • Gangwon National University Hospital
      • Daejeon, Korea, Republic of
        • Chungnam National University Hospital
      • GangNeung, Korea, Republic of
        • Asan Medical Center
      • Gwangju, Korea, Republic of
        • Gwangju Christian Hospital
      • Gyongju, Korea, Republic of
        • Dongguk University Hospital
      • Inchon, Korea, Republic of
        • St.Mary's Catholic Medical Center
      • Jeju, Korea, Republic of
        • Jeju Hanla Hospital
      • Jinju, Korea, Republic of
        • Gyeongsang Uniservity Hospital
      • Seoul, Korea, Republic of
        • Asan Medical Center
      • Seoul, Korea, Republic of
        • Hangang Sacred Heart Hospital
      • Seoul, Korea, Republic of
        • Seoul Veterans Hospital
      • Seoul, Korea, Republic of
        • St.Mary's Catholic Medical Center
      • Suwon, Korea, Republic of
        • Ajou University Hospital
      • Ulsan, Korea, Republic of
        • Ulsan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cypher
Sirolimus-eluting stent
Device: Cypher
Sirolimus-eluting stent implantation
Other Names:
  • Sirolimus-eluting stent
Active Comparator: Xience V
Everolimus-eluting stent
Device: Xience V
Everolimus-eluting Stent implantation
Other Names:
  • Everolimus-eluting Stent

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seung-Jung Park

Collaborators

CardioVascular Research Foundation, Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

October 18, 2009

First Submitted That Met QC Criteria

March 1, 2010

First Posted (Estimate)

March 2, 2010

Study Record Updates

Last Update Posted (Estimate)

August 8, 2012

Last Update Submitted That Met QC Criteria

August 7, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-0250

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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