Efficacy of the SeQuent®Please in the Treatment of De-novo Stenoses Versus Taxus™Liberté™ (PEPCAD-DEBonly)
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Ages Eligible for Study:
19 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Age > 18 years
Clinical evidence of stable or unstable angina or a positive functional study
Single, stenotic de novo lesion in a native coronary artery, type A or selected B1 (see 22.214.171.124 Definition of lesion types)
Diameter stenosis > 70% (visual estimate)
Vessel diameter 2.5 - 3.5 mm
Female patients can enter this study if they are post-menopausal for at least two years or have undergone hysterectomy or sterilization
Signed patient informed consent form
Patient's and treating physician's agree that the patient will return for all required post procedure follow-up assessments as defined in the clinical protocol
Left ventricular ejection fraction of < 30%
Visible thrombus proximal to the lesion
Expection that treatment with devices other than PTCA will be required for this lesion.
Stenosis is within a bypass graft
Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, paclitaxel, or a sensitivity to contrast media which cannot be adequately pre-medicated
Other medical illness (i.e. cancer, liver disease or congestive heart failure) that may require cytostatic or radiation therapy, cause the subject to be non-compliant with the protocol, confound the data interpretation or is associated with limited life-expectancy (i.e., less than two years).
Acute myocardial infarction within the past 72 hours of the intended treatment (de-fined as: Q wave infarction having total creatinine kinase (CK) >3 times the upper normal limit, or CK remains elevated above hospital normal at time of treatment)
Chronic renal insufficiency with serum creatinine > 2.0 mg%
Significant gastrointestinal (GI) bleed within the past six months.
History of bleeding diathesis or coagulopathy or will refuse blood transfusions
Extensive peripheral vascular disease that precludes safe 6 French sheath insertion and / or requires additional anti-platelet and / or anti-coagulation treatment.
Participating in another device or drug study within the last 6 months which may inter-fere with the interpretation of results of this study