Coronary Artery Disease, Atherosclerosis, Stable Angina, Unstable Angina
Conditions
Brief summary
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.
Interventions
DEVICEDrug eluting balloon
Percutaneous transluminal coronary balloon angioplasty catheter eluting paclitaxel
DEVICELiberté
Bare metal stent
DEVICEPTCA balloon catheter
Percutaneous transluminal coronary angioplasty catheter
DEVICETaxus
Paclitaxel eluting stent
Sponsors
UMC Utrecht
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Side branch angiographic Late Lumen Loss (expressed in millimeters) measured by Quantitative Coronary Analysis (QCA) | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Target vessel failure (TVF) | 6 months |
| Major Angiographic coronary or cerebral Events (MACCE) | 6 months |
Countries
Belgium, Netherlands
Outcome results
None listed