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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2010-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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CoroflexTM

highly flexible CoroflexTM Please-Stent features

Group Type ACTIVE_COMPARATOR

CoroflexTM Please

Intervention Type DEVICE

highly flexible CoroflexTM Please-Stent

TAXUS

Paclitaxel-eluting stent

Group Type ACTIVE_COMPARATOR

Paclitaxel-eluting stent

Intervention Type DEVICE

Paclitaxel-eluting stent

Interventions

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CoroflexTM Please

highly flexible CoroflexTM Please-Stent

Intervention Type DEVICE

Paclitaxel-eluting stent

Intervention Type DEVICE

Other Intervention Names

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Taxus liberte

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No