The main objective of this study is to assess the safety and effectiveness of the sirolimus-coated Bx VELOCITY™ stent in maintaining minimum lumen diameter in de novo native coronary artery lesions as compared to the uncoated Bx VELOCITY balloon-expandable stent. Both stents are mounted on the Raptor® Rapid Exchange Stent Delivery System.
This is a multicenter (up to 35 centers), prospective, randomized double blind study. This study has a 2-arm design assessing the safety and effectiveness of the sirolimus-coated Bx VELOCITY stent to the uncoated Bx VELOCITY stent, both mounted on the Raptor Rapid Exchange Stent Delivery System. A total of 350 patients will be entered in the study and will be randomized on a 1:1 basis. Patients will be either randomized to the sirolimus coated or uncoated BX-VELOCITY stent. Patients will be followed at 30 days, 6, 9, and 12 months, and at 2, 3, 4, 5, 6, 7, and 8 years post-procedure, with all patients undergoing repeat angiography at 8 months. Medical resource use during the 5 years follow-up period will be collected and analyzed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
353
drug-eluting stent
bare-metal stent
Herzkatheterlabor und Praxisklinik
Hamburg, Germany
Med. Klinik und Poliklinik
Münster, Germany
In-stent minimum lumen diameter (MLD).
Time frame: 8 months.
Composite of MACE defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat TLR.
Time frame: 1, 6, 9, and 12 months; 2, 3, 4, 5, 6, 7 and 8 years post procedure.
Angiographic binary restenosis (>=50% diameter stenosis).
Time frame: 8 months.
In-lesion MLD.
Time frame: 8 months.
Target lesion revascularization.
Time frame: 9 months.
Target vessel revascularization.
Time frame: 9 months.
Target vessel failure defined as cardiac death, myocardial infarction, or target vessel revascularization.
Time frame: 9 months.
Device success (final residual diameter stenosis of < 50%).
Time frame: any time post-procedure.
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