Treatment of Coronary Artery Disease (CAD) With Bare Metal Stent (BMS) Followed by Paclitaxel-Coated Balloon Catheter Versus Paclitaxel-Eluting Stent

SeQuent 1000 - Treatment of Coronary Artery Disease With Bare Metal Stent Followed by Paclitaxel-Coated Balloon Catheter Versus Paclitaxel-Eluting Stent: Randomized Trial

The purpose of this study is to compare the one-time application of Paclitaxel from SeQuent Please (Paclitaxel-coated Balloon Catheter) after using the Coroflex Blue (Cobalt Chromium Stent) with the slow releasing of small dose of Paclitaxel from the Coroflex Please (Paclitaxel-Eluting Stent) stent system in a non-inferiority trial.

Inclusion Criteria:

• Symptomatic coronary artery disease including patients with chronic stable angina, unstable angina and silent ischemia
• Presence of one or more coronary artery stenosis >50% in a native coronary artery from 2.25 to 3.5 mm in diameter that can be covered with one stent
• One lesion treated with the study device

Exclusion Criteria:

• Pregnancy
• Known intolerance to aspirin, clopidogrel, heparin, stainless steel, paclitaxel, cobalt, chromium or contrast material
• Inability to provide informed consent
• Currently participating in another trial before reaching the primary endpoint
• Elective surgery within 12 months of percutaneous coronary intervention (PCI) unless dual antiplatelet therapy is maintained throughout the peri-surgical period
• Acute or recent myocardial infarction
• left ventricular ejection fraction (LVEF) < 30 %
• Stroke or transient ischemic attack within 6 months
• Stented segment longer than 23 mm
• Vessel diameter of less than 2,5 mm
• Significant calcification, chronic total occlusion (CTO) or thrombus in the target lesion