The Treatment of Coronary De-novo Lesions With the Elutax Paclitaxel-eluting Balloon Alone, a Pilot Study

The Treatment of Coronary De-novo Lesions With the Elutax Paclitaxel-eluting Balloon Alone, a Pilot Study

A randomised open-label pilot study to assess the safety and efficacy of treatment with a drug eluting balloon alone in coronary de novo lesions). Elective patients requiring PCI to coronary de novo lesions in vessels 2.5 mm - 4.0 mm.

Inclusion Criteria:

• Patient ≥ 18years old
• Stable angina symptoms
• Elective treatment to coronary lesion
• Reference vessel diameters of ≥ 2.5mm and ≤ 4.0 mm on visual inspection

Exclusion Criteria:

• Left main stem lesion
• Bifurcation lesions
• Acute coronary syndrome (UAP, NSTEMI, STEMI)
• Cardiogenic shock
• Chronic total occlusion
• Additional lesions requiring PCI
• Platelet count ≤ 50 x 109/mm3
• Left ventricular ejection fraction ≤ 30%
• Patient life expectancy less than 12 months
• Known allergies to aspirin, clopidogrel, prasugrel, heparin, stainless steel, intravenous contrast (severe), or paclitaxel
• Participation in another investigational drug or device study
• Patient unable to give informed consent