Coronary Artery Disease
Conditions
Keywords
Coronary Artery Disease, stent
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.
Interventions
DEVICECoroflexTM Please
highly flexible CoroflexTM Please-Stent
DEVICEPaclitaxel-eluting stent
Paclitaxel-eluting stent
Sponsors
CardioVascular Research Foundation, Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In-segment late lumen loss by quantitative coronary angiographic measurements | 9 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| All Death | 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 |
| 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 |
| Stent thrombosis (by ARC definition) | 12 months |
Countries
South Korea
Outcome results
None listed