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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CoroflexTM Please
Paclitaxel-eluting stent
Sponsored by
CardioVascular Research Foundation, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, stent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Soonchunhyang University Bucheon Hospital
  • Chungnam National University Hospital
  • Asan Medical Center
  • Kwangju Christian Hospital
  • Hallym University Sacred Heart Hospital
  • Asan Medical Center
  • Hangang Sacred Heart Hospital
  • Seoul Veterans Hospital
  • Ajou University Hospital
  • Ulsan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

CoroflexTM

TAXUS

Arm Description

highly flexible CoroflexTM Please-Stent features

Paclitaxel-eluting stent

Outcomes

Primary Outcome Measures

In-segment late lumen loss by quantitative coronary angiographic measurements

Secondary Outcome Measures

All Death
Cardiac death
Myocardial infarction
Target vessel revascularization (all and ischemia-driven)
Target lesion revascularization (all and ischemia-driven)
Stent thrombosis (by ARC definition)
In-stent late loss at 9 month angiographic follow-up
Binary restenosis in both in-stent and in-segment
Angiographic pattern of restenosis
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

Full Information

First Posted
October 14, 2009
Last Updated
August 17, 2010
Sponsor
CardioVascular Research Foundation, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT00995423
Brief Title
Comparison of Paclitaxel-Eluting Coroflex Please Stent Versus Paclitaxel-Eluting Stent
Acronym
PIPA
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 Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
CardioVascular Research Foundation, Korea

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary Artery Disease, stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CoroflexTM
Arm Type
Active Comparator
Arm Description
highly flexible CoroflexTM Please-Stent features
Arm Title
TAXUS
Arm Type
Active Comparator
Arm Description
Paclitaxel-eluting stent
Intervention Type
Device
Intervention Name(s)
CoroflexTM Please
Intervention Description
highly flexible CoroflexTM Please-Stent
Intervention Type
Device
Intervention Name(s)
Paclitaxel-eluting stent
Other Intervention Name(s)
Taxus liberte
Intervention Description
Paclitaxel-eluting stent
Primary Outcome Measure Information:
Title
In-segment late lumen loss by quantitative coronary angiographic measurements
Time Frame
9 months
Secondary Outcome Measure Information:
Title
All Death
Time Frame
12 months
Title
Cardiac death
Time Frame
12 months
Title
Myocardial infarction
Time Frame
12 month
Title
Target vessel revascularization (all and ischemia-driven)
Time Frame
12 month
Title
Target lesion revascularization (all and ischemia-driven)
Time Frame
12 months
Title
Stent thrombosis (by ARC definition)
Time Frame
12 months
Title
In-stent late loss at 9 month angiographic follow-up
Time Frame
12 months
Title
Binary restenosis in both in-stent and in-segment
Time Frame
9 month
Title
Angiographic pattern of restenosis
Time Frame
9 months
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung-Jung Park Park, MD, PhD
Organizational Affiliation
Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soonchunhyang University Bucheon Hospital
City
Bucheon
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
GangNeung
Country
Korea, Republic of
Facility Name
Kwangju Christian Hospital
City
Kwangju
Country
Korea, Republic of
Facility Name
Hallym University Sacred Heart Hospital
City
PyeongChon
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Hangang Sacred Heart Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Veterans Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon
Country
Korea, Republic of
Facility Name
Ulsan University Hospital
City
Ulsan
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Comparison of Paclitaxel-Eluting Coroflex Please Stent Versus Paclitaxel-Eluting Stent

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