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

This study has been completed.
Sponsor:
Information provided by:
CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:
NCT00995423
First received: October 14, 2009
Last updated: August 17, 2010
Last verified: August 2010
  Purpose

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 Intervention Phase
Coronary Artery Disease
Device: CoroflexTM Please
Device: Paclitaxel-eluting stent
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: Comparison of the Efficacy and Safety of Paclitaxel-Eluting CoroflexTM Please Stent Versus Paclitaxel-Eluting Stent in Patients With Coronary Artery Disease

Resource links provided by NLM:


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

Primary Outcome Measures:
  • In-segment late lumen loss by quantitative coronary angiographic measurements [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • All Death [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Cardiac death [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
  • Target vessel revascularization (all and ischemia-driven) [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
  • Target lesion revascularization (all and ischemia-driven) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Stent thrombosis (by ARC definition) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • In-stent late loss at 9 month angiographic follow-up [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Binary restenosis in both in-stent and in-segment [ Time Frame: 9 month ] [ Designated as safety issue: Yes ]
  • Angiographic pattern of restenosis [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 500
Study Start Date: April 2008
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CoroflexTM
highly flexible CoroflexTM Please-Stent features
Device: CoroflexTM Please
highly flexible CoroflexTM Please-Stent
Other Name: CoroflexTM Please
Active Comparator: TAXUS
Paclitaxel-eluting stent
Device: Paclitaxel-eluting stent
Paclitaxel-eluting stent
Other Name: Taxus liberte

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.

  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 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00995423

Locations
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
Investigators
Principal Investigator: Seung-Jung Park Park, MD, PhD Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
  More Information

No publications provided

Responsible Party: Seung-Jung Park, CardioVascular Research Foundation
ClinicalTrials.gov Identifier: NCT00995423     History of Changes
Other Study ID Numbers: 2007-0497
Study First Received: October 14, 2009
Last Updated: August 17, 2010
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
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014