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
1 other identifier
interventional
500
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 coronary-artery-disease
Started Apr 2008
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 14, 2009
CompletedFirst Posted
Study publicly available on registry
October 15, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedAugust 18, 2010
August 1, 2010
2.3 years
October 14, 2009
August 17, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
In-segment late lumen loss by quantitative coronary angiographic measurements
9 months
Secondary Outcomes (10)
All Death
12 months
Cardiac death
12 months
Myocardial infarction
12 month
Target vessel revascularization (all and ischemia-driven)
12 month
Target lesion revascularization (all and ischemia-driven)
12 months
- +5 more secondary outcomes
Study Arms (2)
CoroflexTM
ACTIVE COMPARATORhighly flexible CoroflexTM Please-Stent features
TAXUS
ACTIVE COMPARATORPaclitaxel-eluting stent
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Soonchunhyang University Bucheon Hospital
Bucheon-si, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Asan Medical Center
Gangneung, South Korea
Kwangju Christian Hospital
Kwangju, South Korea
Hallym University Sacred Heart Hospital
Pyeongchon, South Korea
Asan Medical Center
Seoul, South Korea
Hangang Sacred Heart Hospital
Seoul, South Korea
Seoul Veterans Hospital
Seoul, South Korea
Ajou University Hospital
Suwon, South Korea
Ulsan University Hospital
Ulsan, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seung-Jung Park Park, MD, PhD
Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 14, 2009
First Posted
October 15, 2009
Study Start
April 1, 2008
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
August 18, 2010
Record last verified: 2010-08