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

Study Overview
=================
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.

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

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: CoroflexTM Please
* Device: Paclitaxel-eluting stent


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CoroflexTM<br>highly flexible CoroflexTM Please-Stent features | Device: CoroflexTM Please<br>* highly flexible CoroflexTM Please-Stent<br>|
| Active Comparator: TAXUS<br>Paclitaxel-eluting stent | Device: Paclitaxel-eluting stent<br>* Paclitaxel-eluting stent<br>* Other names: Taxus liberte;|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Stent thrombosis (by ARC definition) |  | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary Artery Disease, stent