DEBlue Stent vs Cypher Stent in the Treatment of Advanced Coronary Artery Disease

Inclusion Criteria

• •Patients with stable or unstable angina or documented ischemia due to a significant lesion in a native coronary artery
• •Patients eligible for coronary revascularization by means of PCI
• •Intention to treat one lesion with one stent
• •Patients suitable for coronary revascularization of any sort (balloon angioplasty, device-assisted balloon-angioplasty, or coronary artery bypass grafting)
• •Patients must be ≥ 18 years of age
• •Women of childbearing potential may not be pregnant nor have the desire to becoming pregnant during the first year following the study procedure. Hence, patients will be advised to use an adequate birth control method up to and including 9 months follow-up
• •Patients who are mentally and linguistically able to understand the aim of the study and to show sufficient compliance in following the study protocol
• •Patients must agree to undergo the 9 months angiographic follow-up
• •Patients must agree to undergo the 1 and 3 year clinical follow-up
• •Patient is able to verbally acknowledge an understanding of the associated risks, benefits, and treatment alternatives to therapeutic options of this trial, e.g. balloon angioplasty by means of the Paclitaxel-eluting PTCA-balloon catheter in combination with the Coroflex BlueTM stent or the Sirolimus-eluting CypherTM stent. The patients, by providing informed consent, agree to these risks and benefits as stated in the patient informed consent document.
• •Significant stenoses in native coronary arteries with nominal stent diameters between ≥ 2.5 mm and ≤ 3.5 mm and \< 24 mm in length