Drug-eluting Balloon in Bifurcations Trial

A Prospective Three-arm Multi-center Study to Investigate Procedural, Clinical and Angiographic Outcomes Using a Drug Eluting Balloon Versus a Standard Balloon in Combination With a Bare Metal Stent and a DES Stent, Following the Provisional Side Branch T-stenting Approach, in Patients With Complex Lesions

The purpose of the DEBIUT study is to assess procedural, clinical and angiographic outcomes of:

1. Provisional T-stenting use for dilation the Paclitaxel-eluting PCI-balloon (DiorTM) in comparison to dilation with a standard balloon prior to the implant of the Liberty Bare Metal Stent in bifurcation lesions (with side branch involvement).
2. Comparison of the results above with the results of using a standard balloon prior to provisional T-stenting with the Paclitaxel-eluting stent TaxusTM LibertéTM.

Inclusion Criteria:

• Stable angina pectoris (CCS class 1,2,3,4) or unstable angina and documented ischemia or silent ischemia
• Patients eligible for coronary revascularisation
• The target bifurcation lesion has a major native coronary artery (>2.5mm) with a stenosis > 50% (on visual assessment) located at a side branch (>2mm)
• Patient must be acceptable for CABG
• De novo lesion
• The main vessel lesion can be covered by one stent (up to 32mm)
• Only one target lesion can be included in the study: other lesions in different vessels are successfully treated before the treatment of the target lesion (residual stenosis <30%, stent well deployed, no residual dissection, normal TIMI flow, no chest pain, ECG unchanged compared to pre-procedural ECG)
• Signed patients informed consent

Exclusion Criteria:

• Patient unable to give informed consent
• Patients with a previous PCI in the target vessel
• Patients with in stent restenosis of target lesion
• Left ventricular ejection fraction more than 30%
• Patients with left main disease
• Severe calcifications with an undilatable lesion during balloon predilatation
• History of bleeding diathesis
• Untreated significant lesion greater than 50% diameter stenosis remaining proximal or distal to the target intervention.
• Patient has suffered a stroke or TIA within the past 3 months
• Life expectancy < 1 year
• Any major surgery planned or required during the next 6 months
• Acute Myocardial Infarction
• Only one target lesion can be included in the study
• Allergy to contrast and/or required anti-platelet medication
• Patients unwilling to return for follow-up at 6 months