Randomized Trial of Coronary Angioplasty for de Novo Lesions in sMall vesSElS With Drug Eluting Balloon.

Recent studies have reported the efficacy of the local application of paclitaxel ® inhibiting neointimal proliferation, and thus the limitation of restenosis, which has led to the conception and development of drug-coated balloon or "Drug Eluting Balloons" (DEB), releasing the antiproliferative drug at the time of expansion. Initially they were applied in the treatment of in-stent restenosis. However, DEB may represent a therapeutic alternative in other contexts where anatomo-clinical uses are not always therapeutic percutaneous coronary revascularization with stent implantation, as is the case of coronary lesions located in small vessels.

Inclusion criteria

• Older than 18, informed consent.
• Evidence of CAD with severe de novo lesion in the native coronary arteries ( ≥70% stenosis by visual estimation or >50% by CT scan); affecting
• Vessels between 2,25 and 2,75 mm diameter and
• The length of the coronary stenosis ≤25 mm
• Patient informed consent form signed.

Exclusion criteria

• Lesion in coronary left main ,
• Chronic total occlusions,
• Lesions at bifurcation,
• Severe calcified lesions,
• Lesions in aorto-coronary saphenous veins or arterial grafts,
• Acute Myocardial Infarction during 48 hours before the procedure,
• Severe renal dysfunction,
• Hypersensibility, allergy or contraindication of medication: acetylsalicylic acid, clopidogrel, ticlopidine, heparin, paclitaxel,
• Allergy to contrast media,
• Life expectancy less than 1 year,
• 1 year FU not guaranteed,
• Being participating in another study.