Efficacy of the SeQuent®Please in the Treatment of De-novo Stenoses Versus Taxus™Liberté™

Randomized Trial on the Treatment of Coronary De-novo Lesions With a Drug Eluting Stent or a Drug Coated Balloon

The aim of the trial is to assess the efficacy of the Paclitaxel-coated SeQuent®Please angioplasty balloon in the treatment of stenoses in native coronary arteries compared to a drug eluting stent.

Inclusion Criteria:

• 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 4.3.1.1 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

Exclusion Criteria:

• 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