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

Comparison of the Efficacy and Safety of Paclitaxel-Eluting CoroflexTM Please Stent Versus Paclitaxel-Eluting Stent in Patients With Coronary Artery Disease

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: CoroflexTM Please; Device: Paclitaxel-eluting 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.

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Bucheon, Korea, Republic of
    • SoonChunHyang University Bucheon Hospital
  • Daejeon, Korea, Republic of
    • Chungnam National University Hospital
  • GangNeung, Korea, Republic of
    • Asan Medical Center
  • Kwangju, Korea, Republic of
    • Kwangju Christian Hospital
  • PyeongChon, Korea, Republic of
    • Hallym University Sacred Heart Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Hangang Sacred Heart Hospital
  • Seoul, Korea, Republic of
    • Seoul Veterans Hospital
  • Suwon, Korea, Republic of
    • Ajou University Hospital
  • Ulsan, Korea, Republic of
    • Ulsan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Taxus liberte

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
In-segment late lumen loss by quantitative coronary angiographic measurements	9 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Cardiac death	12 months
All Death	12 months
Stent thrombosis (by ARC definition)	12 months
Myocardial infarction	12 month
Target vessel revascularization (all and ischemia-driven)	12 month
Target lesion revascularization (all and ischemia-driven)	12 months
In-stent late loss at 9 month angiographic follow-up	12 months
Binary restenosis in both in-stent and in-segment	9 month
Angiographic pattern of restenosis	9 months

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: October 14, 2009
• First Submitted That Met QC Criteria: October 14, 2009
• First Posted (Estimate): October 15, 2009

Study Record Updates

• Last Update Posted (Estimate): August 18, 2010
• Last Update Submitted That Met QC Criteria: August 17, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; stent
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: 2007-0497