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

Launched by ANDRES IÑIGUEZ ROMO, MD, PHD · Nov 5, 2012

Keywords

ClinConnect Summary

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 ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Older than 18, informed consent.
• • 2. Evidence of CAD with severe de novo lesion in the native coronary arteries ( ≥70% stenosis by visual estimation or \>50% by CT scan); affecting
• • 3. Vessels between 2,25 and 2,75 mm diameter and
• • 4. The length of the coronary stenosis ≤25 mm
• • 5. Patient informed consent form signed.
• Exclusion Criteria:
• • 1. Lesion in coronary left main ,
• • 2. Chronic total occlusions,
• • 3. Lesions at bifurcation,
• • 4. Severe calcified lesions,
• • 5. Lesions in aorto-coronary saphenous veins or arterial grafts,
• • 6. Acute Myocardial Infarction during 48 hours before the procedure,
• • 7. Severe renal dysfunction,
• • 8. Hypersensibility, allergy or contraindication of medication: acetylsalicylic acid, clopidogrel, ticlopidine, heparin, paclitaxel,
• • 9. Allergy to contrast media,
• • 10. Life expectancy less than 1 year,
• • 11. 1 year FU not guaranteed,
• • 12. Being participating in another study.