The Paclitaxel-Eluting Percutaneous Transluminal Coronary Angioplasty (PTCA) - Balloon Catheter in Coronary Artery Disease to Treat Chronic Total Occlusions

The Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease to Treat Chronic Total Occlusions

The aim of the study is to assess the safety and efficacy of a Paclitaxel-eluting PTCA-balloon in combination with bare-metal stenting for treatment of chronic total occlusions in native coronary arteries with reference diameters between 2.5 mm and 4.0 mm.

Inclusion Criteria:

• chronic total occlusion
• Thrombolysis in Myocardial Infarction (TIMI) flow 0 or 1
• occlusion in native coronary artery
• indication for percutaneous coronary intervention based on symptoms, prognosis or evidence of ischemia
• reference diameter 2.5 mm to 4.0 mm

Exclusion Criteria:

• saphenous vein graft
• bifurcation lesion with need to stent main and side branch
• left main occlusion
• de-novo stenosis (no occlusion)
• restenosis
• in-stent restenosis
• contraindication for dual antiplatelet therapy with acetylsalicylic acid and clopidogrel for 6 months
• coronary aneurysm at target lesion