Drug-eluting Balloon in Bifurcations Trial

Study Overview
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Brief Summary
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The purpose of the DEBIUT study is to assess procedural, clinical and angiographic outcomes of: 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). 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.

Official Title
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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

Conditions
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Coronary Artery Disease, Atherosclerosis, Stable Angina, Unstable Angina

Intervention / Treatment
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* Device: Drug eluting balloon
* Device: Liberté
* Device: PTCA balloon catheter
* Device: Taxus


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Use of Dior balloon and implant of Liberté Bare Metal Stent | Device: Drug eluting balloon<br>* Percutaneous transluminal coronary balloon angioplasty catheter eluting paclitaxel<br>* Other names: Dior (EuroCor);Device: Liberté<br>* Bare metal stent<br>* Other names: Liberté (Boston Scientific);|
| Active Comparator: 2<br>Use of standard balloon and implant of Liberté Bare Metal Stent | Device: Liberté<br>* Bare metal stent<br>* Other names: Liberté (Boston Scientific);Device: PTCA balloon catheter<br>* Percutaneous transluminal coronary angioplasty catheter<br>* Other names: Any PTCA catheter;|
| Active Comparator: 3<br>Use of standard balloon and implant of Taxus Liberté Drug Eluting Stent | Device: PTCA balloon catheter<br>* Percutaneous transluminal coronary angioplasty catheter<br>* Other names: Any PTCA catheter;Device: Taxus<br>* Paclitaxel eluting stent<br>* Other names: Taxus Liberté (Boston scientific);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side branch angiographic Late Lumen Loss (expressed in millimeters) measured by Quantitative Coronary Analysis (QCA) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target vessel failure (TVF) |  | 6 months | 
| Major Angiographic coronary or cerebral Events (MACCE) |  | 6 months |