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Comparison of Paclitaxel-Eluting Coroflex Please Stent Versus Paclitaxel-Eluting Stent (PIPA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00995423
Recruitment Status : Completed
First Posted : October 15, 2009
Last Update Posted : August 18, 2010
Information provided by:
CardioVascular Research Foundation, Korea

Brief Summary:
The purpose of this study is to assess whether the outcome of treatment with CoroflexTM Please stent is not inferior to the outcome of treatment with TAXUS stent.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: CoroflexTM Please Device: Paclitaxel-eluting stent Phase 4

Detailed Description:
To establish the effectiveness and the safety of coronary stenting with the newly developed paclitaxel-eluting balloon expandable stent (CoroflexTM Please stent, B. Bran, Melsungen, Germany), compared to the conventional paclitaxel-eluting balloon expandable stent (TAXUS stent, Boston scientific) in the treatment of coronary stenosis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of the Efficacy and Safety of Paclitaxel-Eluting CoroflexTM Please Stent Versus Paclitaxel-Eluting Stent in Patients With Coronary Artery Disease
Study Start Date : April 2008
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arm Intervention/treatment
Active Comparator: CoroflexTM
highly flexible CoroflexTM Please-Stent features
Device: CoroflexTM Please
highly flexible CoroflexTM Please-Stent

Active Comparator: TAXUS
Paclitaxel-eluting stent
Device: Paclitaxel-eluting stent
Paclitaxel-eluting stent
Other Name: Taxus liberte

Primary Outcome Measures :
  1. In-segment late lumen loss by quantitative coronary angiographic measurements [ Time Frame: 9 months ]

Secondary Outcome Measures :
  1. All Death [ Time Frame: 12 months ]
  2. Cardiac death [ Time Frame: 12 months ]
  3. Myocardial infarction [ Time Frame: 12 month ]
  4. Target vessel revascularization (all and ischemia-driven) [ Time Frame: 12 month ]
  5. Target lesion revascularization (all and ischemia-driven) [ Time Frame: 12 months ]
  6. Stent thrombosis (by ARC definition) [ Time Frame: 12 months ]
  7. In-stent late loss at 9 month angiographic follow-up [ Time Frame: 12 months ]
  8. Binary restenosis in both in-stent and in-segment [ Time Frame: 9 month ]
  9. Angiographic pattern of restenosis [ Time Frame: 9 months ]
  10. 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 [ Time Frame: during the hospital stay ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • The patient must be at least 18 years of age
  • Significant de novo coronary artery stenosis (>50% by visual estimation)
  • 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 patents with atypical chest pain or without symptoms but having documented myocardial ischemia, amenable to stent-assisted percutaneous coronary intervention
  • 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:

  • The patient has a known hypersensitivity or contraindication to any of the following medications:

    • Heparin
    • Aspirin
    • Both Clopidogrel and TIclopidine
    • Sirolimus, paclitaxel
    • 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)
  • Systemic (intravenous) Sirolimus or paclitaxel use within 12 months
  • Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
  • History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions
  • Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months
  • Current known current platelet count <100,000 cells/mm3 or Hgb <10 g/dL
  • An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 12 months post enrollment
  • 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)
  • Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period
  • Patients with EF<25%
  • Cardiogenic shock at entry
  • Acute MI patients within symptom onset < 12 hours needing primary angioplasty
  • Creatinine level > 3.0mg/dL or dependence on dialysis
  • Patients with left main stem stenosis (>50% by visual estimate)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00995423

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Korea, Republic of
Soonchunhyang University Bucheon Hospital
Bucheon, Korea, Republic of
Chungnam National University Hospital
Daejeon, Korea, Republic of
Asan Medical Center
GangNeung, Korea, Republic of
Kwangju Christian Hospital
Kwangju, Korea, Republic of
Hallym University Sacred Heart Hospital
PyeongChon, 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
Ajou University Hospital
Suwon, Korea, Republic of
Ulsan University Hospital
Ulsan, Korea, Republic of
Sponsors and Collaborators
CardioVascular Research Foundation, Korea
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Principal Investigator: Seung-Jung Park Park, MD, PhD Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine

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Responsible Party: Seung-Jung Park, CardioVascular Research Foundation Identifier: NCT00995423    
Other Study ID Numbers: 2007-0497
First Posted: October 15, 2009    Key Record Dates
Last Update Posted: August 18, 2010
Last Verified: August 2010
Keywords provided by CardioVascular Research Foundation, Korea:
Coronary Artery Disease
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action