INDICOR The Paclitaxel-Eluting PTCA-Balloon Catheter in Combination With a Cobalt-Chromium Stent

Exclusion Criteria

• •Patient Related
• •Patients with acute (\< 24 h) or recent (≤ 48 hours) myocardial infarction
• •Patients with unstable angina pectoris (Braunwald class 3)
• •Patients with severe congestive heart failure
• •Patients with severe heart failure NYHA IV
• •Patients demonstrating clinical signs of cardiogenic shock at the time of the procedure (systolic blood pressure of less than 80 mm Hg requiring inotropic support, IABP and/or fluid challenge).
• •Patients with severe valvular heart disease
• •Women who are pregnant or lactating
• •Patients with life expectancy of less than five years or factors making clinical follow-up difficult
• •Patients with bleeding diathesis in whom anticoagulation or anti-platelet medication is contraindicated
• •Patients who had a cerebral stroke \< 6 months prior to the procedure
• •Patient participates in other clinical trials involving any investigational device or drug
• •Untreated hyperthyroidism
• •Post transplantation of any organ or immune suppressive medication
• •Other disease to jeopardize follow-up (e.g., malignancy)
• •Addiction to any drug or to alcohol
• •Patients with any type of surgery during the week preceding the interventional procedure
• •Patients with percutaneous coronary intervention during the six months prior to enrollment into this study
• •Lesion Related
• •Evidence of extensive thrombosis within target vessel before the intervention
• •Side branch \> 2 mm in diameter originating from the lesion
• •Percutaneous coronary intervention of venous graft
• •Target segment is occluded of (i.e., acute or chronic)
• •In-stent restenosis (restenoses in non-stented segments are permitted)
• •Ostial lesion within 2 mm of vessel origin
• •Patients with another coronary stent implanted previously into the target vessel proximal to the target lesion