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LONG-DES VI (Drug Eluting Stent for Long Lesions in Coronary Artery)

Sponsor
Seung-Jung Park (Other)
Overall Status
Terminated
CT.gov ID
NCT01489761
Collaborator
Abbott (Industry), CardioVascular Research Foundation, Korea (Other)
302
Enrollment
11
Locations
2
Arms
61.5
Actual Duration (Months)
27.5
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a multi-center, randomized, study to compare the efficacy of zotarolimus-eluting stent (Resolute Integrity or Resolute Onyx stent) or everolimus-eluting stent (Xience Prime or Xience Xpedition or Xience Alpine stent) for very long coronary lesions.

Condition or Disease Intervention/Treatment Phase
  • Device: percutaneous coronary intervention
 Phase 4

Detailed Description

Following angiography, patients with significant diameter stenosis > 50% and lesion length (> 50mm) requiring at least 2 multiple long-stent placement by visual estimation and eligible for LONG-DES VI trial inclusion and exclusion criteria will be randomized 1:1 to zotarolimus-eluting stent (Resolute Integrity or Resolute Onyx stent) or everolimus-eluting stent (Xience Prime or Xience Xpedition or Xience Alpine stent) by the stratified randomization method.

Study Design

Study Type:
Interventional
Actual Enrollment :
302 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Percutaneous Treatment of Very LONG Native Coronary Lesions With Drug-Eluting Stent-VI: Everolimus-eluting Versus Zotarolimus-Eluting Stents
Actual Study Start Date :
Jan 1, 2012
Actual Primary Completion Date :
Feb 14, 2017
Actual Study Completion Date :
Feb 14, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: zotarolimus-eluting stent

Resolute Integrity or Resolute Onyx stent

Device: percutaneous coronary intervention
drug eluting stent implantation
Other Names:
  • Resolute Integrity or Resolute Onyx stent
  • Xience Prime or Xience Xpedition or Xience Alpine stent

    		•
    Experimental: everolimus-eluting stent

    Xience Prime or Xience Xpedition or Xience Alpine stent

    Device: percutaneous coronary intervention
    drug eluting stent implantation
    Other Names:
  • Resolute Integrity or Resolute Onyx stent
  • Xience Prime or Xience Xpedition or Xience Alpine stent

    		•

    Outcome Measures

    Primary Outcome Measures

    1. In-segment late luminal loss at 13 month follow-up [13 month post stenting]

    Secondary Outcome Measures

    1. 1. All Death [12 month clinical follow-up]

    2. 2. Cardiac death [12 month clinical follow-up]

    3. 3. Myocardial infarction (MI) [12 month clinical follow-up]

    4. 4. Composite of death or MI [12 month clinical follow-up]

    5. 5. Composite of cardiac death or MI [12 month clinical follow-up]

    6. 6. Target vessel revascularization (ischemia-driven and clinically-driven) [12 month clinical follow-up]

    7. 7. Target lesion revascularization (ischemia-driven and clinically-driven) [12 month clinical follow-up]

    8. 8. Target-vessel failure (death from any cause, myocardial infarction, and ischemic-driven target-vessel revascularization) [12 month clinical follow-up]

    9. 9. Stent thrombosis (ARC criteria) [12 month clinical follow-up]

    10. 10. In-stent late loss [13 month angiographic follow-up]

    11. 11. In-stent and in-segment restenosis [13 month angiographic follow-up]

    12. 12. Angiographic pattern of restenosis [13 month angiographic follow-up]

    13. 13. Volume of intimal hyperplasia [13 month IVUS follow-up]

      sub-study

    14. 14. Incidence of late stent malapposition [13 month IVUS follow-up]

      sub-study

    15. 15. 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 [2-3 days post stenting]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Age more than 20 years

    • Significant native coronary artery stenosis (> 50% by visual estimate) with lesion length of more than 50mm, which requires at least 2 multiple long stent placement without intervening normal segment

    • Patients with silent ischemia, stable or unstable angina pectoris, and Non-ST-elevation myocardial infarction (NSTEMI)

    • 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, zotarolimus, 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) However, non-target vessel In-stent restenosis is permitted

    • Patients with EF < 30%

    • Serum creatinine level >=2.0mg/dL or dependence on dialysis

    • Patients with left main stem stenosis (> 50% visual estimate)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gangwon National Univ. Hospital Chuncheon Korea, Republic of
    2 Keimyung University Dongsan Medical Center Daegu Korea, Republic of
    3 Kyungpook National university hospital Daegu Korea, Republic of
    4 The Catholic University of Korea, Daejeon ST. Mary's Hospital Daejeon Korea, Republic of
    5 Chonnam National University Hospital Gwangju Korea, Republic of
    6 National Health Insurance Service Ilsan Hospital Ilsan Korea, Republic of
    7 Korea University Guro Hospital Seoul Korea, Republic of
    8 Kyunghee University Medical Center Seoul Korea, Republic of
    9 The Catholic University of Korea, Yeouido St. Mary's Hospital Seoul Korea, Republic of
    10 St.carollo Hospital Suncheon Korea, Republic of
    11 Pusan National University Yangsan Hospital Yangsan Korea, Republic of

    Sponsors and Collaborators

    • Seung-Jung Park
    • Abbott
    • CardioVascular Research Foundation, Korea

    Investigators

    • Principal Investigator: Seung-Jung Park, MD, PhD, Asan Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Seung-Jung Park, MD,PhD, CardioVascular Research Foundation, Korea
    ClinicalTrials.gov Identifier:
    NCT01489761
    Other Study ID Numbers:
    • CVRF2011-9
    First Posted:
    Dec 12, 2011
    Last Update Posted:
    Feb 24, 2017
    Last Verified:
    Feb 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Seung-Jung Park, MD,PhD, CardioVascular Research Foundation, Korea
    long lesions
    drug eluting stents
    Additional relevant MeSH terms:
    Coronary Artery Disease

    Study Results

    No Results Posted as of Feb 24, 2017