The objective of this study is to assess the feasibility and safety of the sirolimus-coated Bx VELOCITY Balloon-Expandable Stent in treating patients with true bifurcation lesions.
This is a prospective, randomized study that will be conducted at up to 5 centers in Europe and the US. All patients who meet the eligibility criteria will be treated with the sirolimus-coated Bx VELOCITY Balloon-Expandable Stent and Stent Delivery System (SDS). As a secondary objective, patients will be randomized in a 1:1 ratio to receive one stent in the main branch with balloon angioplasty by a kissing balloon technique in the side branch (stent/PTCA group), or to receive stents in both the main and side branches (stent/stent group). It is anticipated that up to 70% of the patients enrolled in the stent/PTCA group will be considered treatment failures and require a stent in the side branch. These patients will have a sirolimus-coated stent placed in the side branch and will be followed per the protocol, but will be analyzed separately. Therefore, it is anticipated that up to 75 patients will be enrolled in the trial. All patients will have repeat angiography at six months, with clinical follow-up to 5 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
86
PCI
PCI
Centre Cuore Columbus
Milan, Italy
percent residual diameter stenosis (%DS) in the stented branch as measured by quantitative coronary angiography (QCA)
Time frame: 6-months post-procedure
device success defined as achievement of a final residual diameter stenosis of < 50% (by QCA), using the assigned device/treatment only
Time frame: anytime during the course of the study
procedure success defined as achievement of a final diameter stenosis of < 50% (by QCA) using any percutaneous method, without the occurrence of death, myocardial infarction (MI), or repeat revascularization of the target lesion during the hospital stay
Time frame: anytime during the course of the study
target vessel failure (TVF), defined as a composite of cardiac death, MI, or target vessel revascularization
Time frame: 6, 12, 18, and 24 months post-procedure
lumen and obstruction volume by intravascular ultrasound (IVUS)
Time frame: 6-month post-procedure
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