Status:
COMPLETED
Comparison of Paclitaxel-Eluting Coroflex Please Stent Versus Paclitaxel-Eluting Stent
Lead Sponsor:
CardioVascular Research Foundation, Korea
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2010
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00995423
Start Date
April 1 2008
End Date
August 1 2010
Last Update
August 18 2010
Active Locations (10)
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1
Soonchunhyang University Bucheon Hospital
Bucheon-si, South Korea
2
Chungnam National University Hospital
Daejeon, South Korea
3
Asan Medical Center
Gangneung, South Korea
4
Kwangju Christian Hospital
Kwangju, South Korea