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DES-ISR: Diffuse Type In-Stent Restenosis After Drug-Eluting Stent

Sponsor
Seung-Jung Park (Other)
Overall Status
Completed
CT.gov ID
NCT00485030
Collaborator
CardioVascular Research Foundation, Korea (Other)
60
Enrollment
15
Locations
2
Arms
55
Duration (Months)
4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the best therapeutic option for the treatment of diffuse type post-drug-eluting stent restenosis.

Condition or Disease Intervention/Treatment Phase
  • Device: Cypher
  • Device: Xience-V
 Phase 4

Detailed Description

Despite a significant reduction of angiographic restenosis and the need for repeat revascularization after introduction of DES, post-DES restenosis still occur and the treatment for DES failure is challenging. However, there have been little data for therapeutic strategy for post-DES restenosis, especially diffuse type ISR. Therefore, we need the well-designed randomized trial to achieve the best therapeutic option for the treatment of diffuse type post-DES restenosis.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison Between Drug-Eluting Stents for the Treatment of the Diffuse Type In-Stent Restenosis After Drug-Eluting Stents Implantation: Sirolimus-Eluting vs. Paclitaxel-Eluting Stents
Study Start Date :
Mar 1, 2007
Actual Primary Completion Date :
Sep 1, 2011
Actual Study Completion Date :
Oct 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cypher

sirolimus-eluting stent

Device: Cypher
sirolimus-eluting stent
Other Names:
  • sirolimus-eluting stent

    • Device: Xience-V
    everolimus-eluting stent
    Other Names:
  • everolimus-eluting stent

    		•
    Active Comparator: Xience-V

    everolimus-eluting stent

    Device: Cypher
    sirolimus-eluting stent
    Other Names:
  • sirolimus-eluting stent

    • Device: Xience-V
    everolimus-eluting stent
    Other Names:
  • everolimus-eluting stent

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Binary in-segment angiographic restenosis [at 9 months angiographic follow-up]

    Secondary Outcome Measures

    1. The composite of death, myocardial infarction, and target-vessel revascularization [in-hospital, 1 month, and 9 months after index procedure]

    2. stent thrombosis [in-hospital, 1 month, and 9 months after index procedure]

    3. Late luminal loss [at 8 month angiographic follow-up]

    4. 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]

    Eligibility Criteria

    Criteria

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

    1. The patient must be at least 18 years of age.

    2. Restenosis after drug-eluting stents (>50% by visual estimate)

    3. Lesion length ≥ 10 mm (diffuse type ISR)

    4. Patients with stable (CCS class 1 to 4) or acute coronary syndromes (unstable angina pectoris Braunwald class IB, IC, IIB, IIC, IIIB, IIIC or NSTEMI) or patients with atypical chest pain or without symptoms but having documented myocardial ischemia, amenable to stent-assisted percutaneous coronary intervention

    5. 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:
    1. The patient has a known hypersensitivity or contraindication to any of the following medications:

    • Heparin

    • Aspirin

    • Both Clopidogrel and TIclopidine

    • Sirolimus eluting stent

    • Stainless steel and/or

    • Contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine [e.g. rash] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled).

    1. Systemic (intravenous) Sirolimus use within 12 months.

    2. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.

    3. History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.

    4. Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.

    5. Current known current platelet count <100,000 cells/mm3 or Hgb <10 g/dL.

    6. Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).

    7. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.

    8. Patients with EF<30%.

    9. Acute MI patients within symptom onset < 12 hours needing primary angioplasty

    10. Creatinine level 3.0mg/dL or dependence on dialysis.

    11. Severe hepatic dysfunction (AST and ALT 3 times upper normal reference values).

    12. Patients with left main stem stenosis and left main in-stent restenosis created by DES(>50% by visual estimate)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Soonchunhyang University Bucheon Hospital Bucheon Korea, Republic of
    2 Choeng Ju St.Mary's Hospital Choeng Ju Korea, Republic of
    3 Kangwon National University Hospital Chuncheon Korea, Republic of
    4 Asan Medical Center GangNeung Korea, Republic of
    5 DongGuk University Gyongju Hospital Gyongju Korea, Republic of
    6 Chonbuk National University Hospital Jeonju Korea, Republic of
    7 Kwangju Christian Hospital Kwangju Korea, Republic of
    8 Inje University Pusan Paik Hospital Pusan Korea, Republic of
    9 Hallym University Sacred Heart Hospital, PyeongChon Korea, Republic of
    10 Hallym University Sacred Heart Hospital PyeongChon Korea, Republic of
    11 Asan Medical Center Seoul Korea, Republic of 138-736
    12 Hangang Sacred Heart Hospital Seoul Korea, Republic of
    13 Kyungsang University Hospital Seoul Korea, Republic of
    14 Seoul Veterans Hospital Seoul Korea, Republic of
    15 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    NCT00485030
    Other Study ID Numbers:
    • 20070044
    First Posted:
    Jun 12, 2007
    Last Update Posted:
    Aug 8, 2012
    Last Verified:
    Aug 1, 2012
    Keywords provided by Seung-Jung Park, MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine, CardioVascular Research Foundation, Korea
    coronary artery disease
    stent
    angioplasty
    Additional relevant MeSH terms:
    Sirolimus
    Everolimus

    Study Results

    No Results Posted as of Aug 8, 2012