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

This study has been completed.
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:
NCT01078038
First received: October 18, 2009
Last updated: August 7, 2012
Last verified: August 2012
  Purpose

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


Condition Intervention Phase
Coronary Artery Disease
Device: Cypher
Device: Xience V
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-III: Sirolimus vs. Everolimus-eluting Stent

Resource links provided by NLM:


Further study details as provided by CardioVascular Research Foundation, Korea:

Primary Outcome Measures:
  • In-segment late luminal loss [ Time Frame: 9 month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All Death [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • Cardiac death [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Myocardial infarction (MI) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Composite of death or MI [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Composite of cardiac death or MI [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Target vessel revascularization (ischemia-driven and clinically-driven) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Target lesion revascularization (ischemia-driven and clinically-driven) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Stent thrombosis (ARC criteria) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • In-stent late loss at 9 month angiographic follow-up [ Time Frame: at 9 month angiographic follow-up ] [ Designated as safety issue: No ]
  • In-stent and in-segment restenosis at 9 month angiographic follow-up [ Time Frame: at 9 month angiographic follow-up ] [ Designated as safety issue: No ]
  • Angiographic pattern of restenosis at 9 month angiographic follow-up [ Time Frame: at 9 month angiographic follow-up ] [ Designated as safety issue: No ]
  • Volume of intimal hyperplasia at 9 month IVUS follow-up (sub-study) [ Time Frame: at 9 month angiographic follow-up ] [ Designated as safety issue: No ]
  • Incidence of late stent malapposition at 9 month IVUS follow-up (sub-study) [ Time Frame: at 9 month angiographic follow-up ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    At discharge from the index hospitalization, participants will be followed for the duration of hospital stay, an expected average of 3 days.

  • All Death [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • All Death [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • Cardiac death [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • Cardiac death [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Myocardial infarction (MI) [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • Myocardial infarction (MI) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Composite of death or MI [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • Composite of death or MI [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Composite of cardiac death or MI [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • Composite of cardiac death or MI [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • Target vessel revascularization (ischemia-driven and clinically-driven) [ Time Frame: one month ] [ Designated as safety issue: No ]
  • Target vessel revascularization (ischemia-driven and clinically-driven) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Target lesion revascularization (ischemia-driven and clinically-driven) [ Time Frame: one month ] [ Designated as safety issue: No ]
  • Target lesion revascularization (ischemia-driven and clinically-driven) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Stent thrombosis (ARC criteria) [ Time Frame: one month ] [ Designated as safety issue: Yes ]
  • Stent thrombosis (ARC criteria) [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Enrollment: 451
Study Start Date: June 2008
Study Completion Date: August 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cypher
Sirolimus-eluting stent
Device: Cypher
Sirolimus-eluting stent implantation
Other Name: Sirolimus-eluting stent
Active Comparator: Xience V
Everolimus-eluting stent
Device: Xience V
Everolimus-eluting Stent implantation
Other Name: 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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01078038

Locations
Korea, Republic of
Sam Anyang Hospital
Anyang, Korea, Republic of
Soonchunhyang University Bucheon Hospital
Bucheon, Korea, Republic of
Busan Paik Hospital
Busan, Korea, Republic of
St.Mary's Catholic Medical Center
Busan, Korea, Republic of
Soonchunhyang University Cheonan Hospital
Cheonan, Korea, Republic of
St.Mary's Catholic Medical Center
Cheongju, Korea, Republic of
Gangwon National University Hospital
Chuncheon, Korea, Republic of
Chungnam National University Hospital
Daejeon, Korea, Republic of
Asan Medical Center
GangNeung, Korea, Republic of
Gwangju Christian Hospital
Gwangju, Korea, Republic of
Dongguk University Hospital
Gyongju, Korea, Republic of
St.Mary's Catholic Medical Center
Inchon, Korea, Republic of
Jeju Hanla Hospital
Jeju, Korea, Republic of
Gyeongsang Uniservity Hospital
Jinju, Korea, Republic of
Seoul Veterans Hospital
Seoul, Korea, Republic of
Hangang Sacred Heart Hospital
Seoul, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
St.Mary's Catholic Medical Center
Seoul, Korea, Republic of
Ajou University Hospital
Suwon, Korea, Republic of
Ulsan University Hospital
Ulsan, Korea, Republic of
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
Investigators
Principal Investigator: Seung-Jung Park, MD, PhD Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
  More Information

No publications provided by CardioVascular Research Foundation, Korea

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Seung-Jung Park, MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier: NCT01078038     History of Changes
Other Study ID Numbers: 2008-0250
Study First Received: October 18, 2009
Last Updated: August 7, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by CardioVascular Research Foundation, Korea:
Coronary Artery Disease
Stent

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Everolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 17, 2014